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Document L:2018:302:FULL

Official Journal of the European Union, L 302, 28 November 2018


Display all documents published in this Official Journal
 

ISSN 1977-0677

Official Journal

of the European Union

L 302

European flag  

English edition

Legislation

Volume 61
28 November 2018


Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

Commission Regulation (EU) 2018/1850 of 21 November 2018 registering a geographical indication for a spirit drink in Annex III to Regulation (EC) No 110/2008 (Гроздова ракия от Търговище/Grozdova rakya ot Targovishte (GI))

1

 

*

Commission Implementing Regulation (EU) 2018/1851 of 21 November 2018 entering a name in the register of protected designations of origin and protected geographical indications (Bayrisch Blockmalz/Bayrischer Blockmalz/Echt Bayrisch Blockmalz/Aecht Bayrischer Blockmalz (PGI))

5

 

*

Commission Implementing Regulation (EU) 2018/1852 of 26 November 2018 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications [Mahón-Menorca (PDO)]

7

 

*

Commission Implementing Regulation (EU) 2018/1853 of 27 November 2018 granting a Union authorisation for the biocidal product family Teat disinfectants biocidal product family of CVAS ( 1 )

8

 

 

DECISIONS

 

*

Commission Implementing Decision (EU) 2018/1854 of 27 November 2018 on recognition of the Better Biomass voluntary scheme for demonstrating compliance with the sustainability criteria under Directives 98/70/EC and 2009/28/EC of the European Parliament and of the Council

73

 

*

Commission Implementing Decision (EU) 2018/1855 of 27 November 2018 on greenhouse gas emissions covered by Decision No 406/2009/EC of the European Parliament and of the Council for the year 2016 for each Member State

75

 

*

Commission Implementing Decision (EU) 2018/1856 of 27 November 2018 amending the Annex to Implementing Decision 2014/709/EU concerning animal health control measures relating to African swine fever in certain Member States (notified under document C(2018) 8058)  ( 1 )

78

 

 

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

 

*

Regulation No 39 of the Economic Commission for Europe of the United Nations (UN/ECE) — Uniform provisions concerning the approval of vehicles with regard to the speedometer and odometer equipment including its installation [2018/1857]

106

 

*

Amendments to Regulation No 100 of the Economic Commission for Europe of the United Nations (UN/ECE) — Uniform provisions concerning the approval of vehicles with regard to specific requirements for the electric power train [2018/1858]

114

 

 

Corrigenda

 

*

Corrigendum to Commission Decision (EU) 2018/860 of 7 February 2018 on the Aid Scheme SA.45852 — 2017/C (ex 2017/N) which Germany is planning to implement for Capacity Reserve ( OJ L 153, 15.6.2018 )

115

 


 

(1)   Text with EEA relevance.

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.


II Non-legislative acts

REGULATIONS

28.11.2018   

EN

Official Journal of the European Union

L 302/1


COMMISSION REGULATION (EU) 2018/1850

of 21 November 2018

registering a geographical indication for a spirit drink in Annex III to Regulation (EC) No 110/2008 (‘Гроздова ракия от Търговище/Grozdova rakya ot Targovishte’ (GI))

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 (1), and in particular Article 17(8) thereof,

Whereas:

(1)

The Commission examined Bulgaria's application for registration of the geographical indication ‘Гроздова ракия от Търговище/Grozdova rakya ot Targovishte’ in accordance with Article 17(5) of Regulation (EC) No 110/2008.

(2)

As it concluded that the application complied with Regulation (EC) No 110/2008, the Commission published the main specifications of the technical file in the Official Journal of the European Union (2) pursuant to Article 17(6) of that Regulation.

(3)

As no statement of objection has been received by the Commission under Article 17(7) of Regulation (EC) No 110/2008, the indication ‘Гроздова ракия от Търговище/Grozdova rakya ot Targovishte’ should be registered as a geographical indication in Annex III to that Regulation.

(4)

The name, as published in the Official Journal in order to allow objections to be made, contains a transcription error. Following the correction of that error, the corrected version of the main specifications of the technical file should be published for information.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for Spirit Drinks,

HAS ADOPTED THIS REGULATION:

Article 1

In Annex III to Regulation (EC) No 110/2008, the following entry is added under the product category ‘Wine spirit’:

‘Wine spirit

Гроздова ракия от Търговище/Grozdova rakya ot Targovishte

Bulgaria’

Article 2

The corrected version of the main specifications of the technical file is included in the Annex to this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 November 2018.

For the Commission,

On behalf of the President,

Phil HOGAN

Member of the Commission


(1)  OJ L 39, 13.2.2008, p. 16.

(2)  OJ C 294, 5.9.2017, p. 15.


ANNEX

MAIN SPECIFICATIONS OF THE TECHNICAL FILE

‘ГРОЗДОВА РАКИЯ ОТ ТЪРГОВИЩЕ’/‘GROZDOVA RAKYA OT TARGOVISHTE’

EU No: PGI-BG-01864 – 7.1.2014

1.   Geographical indication to be registered:‘Гроздова ракия от Търговище’/‘Grozdova rakya ot Targovishte’

2.   Category of the spirit drink: Wine spirit

3.   Description of the spirit drink:

3.1.   Physical, chemical and/or organoleptic characteristics

Wine spirit with the geographical indication ‘Гроздова ракия от Търговище’/‘Grozdova rakya ot Targovishte’ has a pale yellow colour, a pleasant aroma of vanilla and a harmonious mild taste. Its specific physico-chemical and organoleptic characteristics are due to the following factors: the raw materials, the geographical area, the method of production and the human factor, which involves applying good manufacturing practices that combine tradition with modern technology.

3.2.   Specific characteristics (compared to spirit drinks of the same category)

Wine spirit with the geographical indication ‘Гроздова ракия от Търговище’/‘Grozdova rakya ot Targovishte’ is produced using a traditional Bulgarian method and has the following physico-chemical properties:

the minimum alcoholic strength of the drink is 40 % vol.;

a volatile substance content (including higher alcohols, total acids, esters and aldehydes) of 267-365 g/hl of 100 % vol. alcohol;

a maximum methanol content of 120 g/hl of 100 % vol. alcohol.

The wood from which the barrels used for maturing the distillate are made and the mineral water which, after softening, is used for diluting the wine distillate also contribute to the drink's distinctive taste.

4.   Geographical area concerned:

Wine spirit with the geographical indication ‘Гроздова ракия от Търговище’/‘Grozdova rakya ot Targovishte’ is produced in the province of Targovishte, which is situated in the eastern part of the Danube plain. The vineyards are located in the municipality of Targovishte, in areas belonging to the following six villages: Kralevo, Dalgach, Ovcharovo, Pevets, Strazha and Ruets.

5.   Method for obtaining the spirit drink:

Wine spirit with the geographical indication ‘Гроздова ракия от Търговище’/‘Grozdova rakya ot Targovishte’ is produced from the following grape varieties:

white — Chardonnay, Rkatsiteli, Muscat Ottonel, Dimyat, Tamyanka, Traminer, Sauvignon Blanc, Aligoté, Riesling Italico;

red — Cabernet Sauvignon and Pamid.

Production begins with the harvesting of the grapes, which are sorted by variety, general outward appearance and sugar content, then pressed. The resultant pulp is macerated in rotary strainers for 4-12 hours. The grape must is then clarified and the clear fractions are transferred on for fermentation. Alcoholic fermentation takes place over approximately 20 days at temperatures of 14-18 °С. The distillate obtained undergoes single or double distillation in a K-5 distillation column until it reaches 65 % vol. alcohol. The K-5 distillation system is a Bulgarian design. The resulting wine spirit is stored in separate compartments for maturing in oak barrels and blending (coupage).

6.   Link with the geographical environment or origin:

6.1.   Details of the geographical area or origin relevant to the link

The geographical area is mostly hilly or undulating. The average elevation is 200–520 m above sea-level. It has a mild, temperate continental climate with maritime influences. Autumns are warm, dry and long, which greatly favours the accumulation of sugars in the grapes. The annual average temperature in the area is approximately 10,7 °C. In terms of annual average precipitation, maximum levels mostly occur in late spring and early summer. The soils in the area are sandy-loamy chernozem and grey forest soils.

6.2.   Specific characteristics of the spirit drink attributable to the geographical area

Wine spirit with the geographical indication ‘Гроздова ракия от Търговище’/‘Grozdova rakya ot Targovishte’ is produced in the province of Targovishte, whose topography, soils and climate combine to create ideal conditions for growing quality grapes that attain optimum technical ripeness. Many of the distinctive qualities of the drink are due to the special oak of the species Quercus Frainetto (Blagun oak), from which the barrels used for maturing the distillate are made. Softened mineral water from the Boaza spring, situated 8 km to the south-west of the city of Targovishte, is used for diluting the distillate. Subsequent blending results in a quality product with stable organoleptic characteristics — a pale yellow colour, a pleasant aroma of vanilla and a harmonious mild taste. The aromatic substances contained in the grapes, which bring out the bouquet and the aroma of the drink, are preserved by using both traditional and modern production methods.

7.   European Union or national/regional provisions:

In Bulgaria, the procedure for approving spirit drinks with a geographical indication is set out in Section VII, ‘Production of spirit drinks with a geographical indication’, of Chapter Nine, ‘Spirit drinks’, of the Wine and Spirit Drinks Act (ZVSN), published in State Gazette No 45 of 15 June 2012.

‘Гроздова ракия от Търговище’/‘Grozdova rakya ot Targovishte’ was approved as a wine spirit with a geographical indication by Order No T-RD-27-13 of the Minister for the Economy of 27 November 2013, which has been published on the Ministry of the Economy's website at: http://www.mi.government.bg/bg/library/zapoved-za-utvarjdavane-na-vinena-destilatna-spirtna-napitka-grozdova-rakiya-s-geografsko-ukazanie-t-68-c28-m361-1.html.

8.   Applicant:

Member State, third country or legal/natural person: Република България, Министерство на икономиката/Republic of Bulgaria, Ministry of the Economy.

Full address (street number and name, town/city and postal code, country):

гр. София 1052, ул. ‘Славянска’ № 8, Република България/8 ul. Slavyanska, 1052 Sofia, Bulgaria

9.   Specific labelling rules:

The rules on the labelling of spirit drinks with a geographical indication produced in Bulgaria and intended for the Bulgarian market are laid down in Article 170(1) and Article 172(1) of the Wine and Spirit Drinks Act.


28.11.2018   

EN

Official Journal of the European Union

L 302/5


COMMISSION IMPLEMENTING REGULATION (EU) 2018/1851

of 21 November 2018

entering a name in the register of protected designations of origin and protected geographical indications (‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’ (PGI))

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 15(1) and Article 52(2) thereof,

Whereas:

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Germany's application to register the name ‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’ was published in the Official Journal of the European Union (2).

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name should therefore be entered in the register.

(3)

By emails received on 19 April 2018 and 21 June 2018, the German authorities notified the Commission that during the national opposition procedure it had been argued that registration of the name ‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’ would jeopardise the existence of an entirely identical name and that products bearing that name had been legally marketed for more than five years preceding the date of publication of the document referred to in Article 50(2)(a) of Regulation (EU) No 1151/2012. They therefore requested that a transitional period, lasting until 31 December 2020, be granted under Article 15(1) of that Regulation to the producer ‘Kalfany Süße Werbung GmbH & Co.KG, D-79336 Herbolzheim’, located outside the geographical area defined for the production of ‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’, which had been legally marketing the product sold under the name ‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’, using this name continuously for more than five years.

(4)

Since the company ‘Kalfany Süße Werbung GmbH & Co.KG, D-79336 Herbolzheim’ meets the requirements laid down in Article 15(1) of Regulation (EU) No 1151/2012 for the granting of a transitional period in which to make legal use of the sales name after registration, it should be granted a transitional period lasting until 31 December 2020 during which time it may make use of the name ‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Agricultural Product Quality Policy Committee,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’ (PGI) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 2.3. – bread, pastry, cakes, confectionery, biscuits and other baker's wares, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

Article 2

The producer ‘Kalfany Süße Werbung GmbH & Co.KG, D-79336 Herbolzheim’, is hereby authorised to continue to use the registered name ‘Bayrisch Blockmalz’/‘Bayrischer Blockmalz’/‘Echt Bayrisch Blockmalz’/‘Aecht Bayrischer Blockmalz’ (PGI) until 31 December 2020.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 November 2018.

For the Commission,

On behalf of the President,

Phil HOGAN

Member of the Commission


(1)  OJ L 343, 14.12.2012, p. 1.

(2)  OJ C 96, 14.3.2018, p. 38.

(3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


28.11.2018   

EN

Official Journal of the European Union

L 302/7


COMMISSION IMPLEMENTING REGULATION (EU) 2018/1852

of 26 November 2018

approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications [‘Mahón-Menorca’ (PDO)]

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Spain's application for the approval of amendments to the specification for the protected designation of origin ‘Mahón-Menorca’, registered under Commission Regulation (EC) No 1107/96 (2) as last amended by Commission Regulation (EC) No 913/2001 (3).

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (4) as required by Article 50(2)(a) of that Regulation.

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

HAS ADOPTED THIS REGULATION:

Article 1

The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Mahón-Menorca’ (PDO) are hereby approved.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 26 November 2018.

For the Commission,

On behalf of the President,

Phil HOGAN

Member of the Commission


(1)  OJ L 343, 14.12.2012, p. 1.

(2)  Commission Regulation (EC) No 1107/96 of 12 June 1996 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/92 (OJ L 148, 21.6.1996, p. 1).

(3)  Commission Regulation (EC) No 913/2001 of 10 May 2001 amending the Annex to Regulation (EC) No 1107/96 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/92 (OJ L 129, 11.5.2001, p. 8).

(4)  OJ C 187, 1.6.2018, p. 13.


28.11.2018   

EN

Official Journal of the European Union

L 302/8


COMMISSION IMPLEMENTING REGULATION (EU) 2018/1853

of 27 November 2018

granting a Union authorisation for the biocidal product family Teat disinfectants biocidal product family of CVAS

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5) thereof,

Whereas:

(1)

On 28 August 2015, the Scientific Consulting Company — SCC GmbH acting on behalf of CVAS Development GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Teat disinfectants biocidal product family of CVAS (‘product family’) of product-type 3, as described in Annex V to that Regulation. The competent authority of Netherlands agreed to evaluate the application as referred to in Article 43(1) of Regulation (EU) No 528/2012. The application was recorded under the case number BC-WU019429-99 in the Register for Biocidal Products (‘the Register’).

(2)

The biocidal product family contains iodine, including polyvinylpyrrolidone iodine, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, and following the entry into application of the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2), the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.

(3)

On 30 August 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4)

On 19 March 2018, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of the product family and the final assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that the product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(5)

On 25 April 2018, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation is granted to CVAS Development GmbH for the biocidal product family Teat disinfectants biocidal product family of CVAS with authorisation number EU-0018724-0000.

The Union authorisation is valid from 18 December 2018 until 30 November 2028.

The Union authorisation is subject to compliance with the SPC set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 27 November 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 167, 27.6.2012, p. 1.

(2)  Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

(3)  ECHA opinion of 7 March 2018 on the Union authorisation of Teat disinfectants biocidal product family of CVAS (ECHA/BPC/193/2018).


ANNEX

Summary of product characteristics for a biocidal product family

TEAT DISINFECTANTS BIOCIDAL PRODUCT FAMILY OF CVAS

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0018724-0000

R4BP 3 asset number: EU-0018724-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name

TEAT DISINFECTANTS BIOCIDAL PRODUCT FAMILY OF CVAS

 

 

1.2.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

 

 

1.3.   Authorisation holder

Name and address of the authorisation holder

Name

CVAS Development GmbH

Address

Dr Albert Reimann Str. 16a, 68526 Ladenburg, Germany

Authorisation number

EU-0018724-0000

R4BP asset number

EU-0018724-0000

Date of the authorisation

18 December 2018

Expiry date of the authorisation

30 November 2028

1.4.   Manufacturer(s) of the biocidal products

Name of manufacturer

Calvatis GmbH

Address of manufacturer

Dr Albert Reimann Str. 16a, 68526 Ladenburg, Germany

Location of manufacturing sites

Dr Albert Reimann Str. 16a, 68526 Ladenburg, Germany


Name of manufacturer

Arthur Schopf Hygiene GmbH & Co. KG

Address of manufacturer

Pfaffensteinstr. 1, 83115 Neubeuern, Germany

Location of manufacturing sites

Pfaffensteinstr. 1, 83115 Neubeuern, Germany

1.5.   Manufacturer(s) of the active substance(s)

Active substance

Iodine

Name of manufacturer

Cosayach Nitratos S.A.

Address of manufacturer

Amunategui 178 Santiago Chile

Location of manufacturing sites

S.C.M. Cosayach Cala Cala Pozo Almonte Chile


Active substance

Iodine

Name of manufacturer

ACF Minera S.A.

Address of manufacturer

San Martín No 499 Iquique Chile

Location of manufacturing sites

Lagunas mine Pozo Almonte Chile


Active substance

Iodine

Name of manufacturer

SQM S.A.

Address of manufacturer

Los Militares 4290, Piso 4 Las Condes Chile

Location of manufacturing sites

Nueva Victoria plant Pedro de Valdivia plant Chile


Active substance

Iodine

Name of manufacturer

Nihon Tennen Gas Co., Ltd/Kanto Natural Gas Development Co., Ltd

Address of manufacturer

661 Mobara 297-8550 Mobara City, Chiba Japan

Location of manufacturing sites

Chiba Plant, 2508 Minami-Hinata 299-4205 Shirako-Machi, Chosei-Gun, Chiba Japan


Active substance

Polyvinylpyrrolidone iodine

Name of manufacturer

Norkem Limited (manufacturer of PVP-iodine)

Address of manufacturer

Norkem House, Bexton Lane WA 16 9FB Knutsford, Cheshire United Kingdom

Location of manufacturing sites

Norkem House, Bexton Lane WA 16 9FB Knutsford, Cheshire United Kingdom

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

 

Active Substance

7553-56-2

231-442-4

0

0,54

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

0

4,16

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

0,33

2.2.   Type(s) of formulation

Formulation(s)

AL — Any other liquid

 

 

PART II

SECOND INFORMATION LEVEL — META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier

meta SPC 1

1.2.   Suffix to the authorisation number

Number

1-1

1.3.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

 

 

2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

 

Active Substance

7553-56-2

231-442-4

0

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

1,16

1,5

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

0

2.2.   Type(s) of formulation of the meta SPC 1

Formulation

AL — Any other liquid

 

 

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

 

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

4.   AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description

Table 1. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual dipping using a dip cup

Application rate(s) and frequency

cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.1.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 2. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated dipping

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.2.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.2.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures: Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

Dip es barriere

Dip es barriere 1.4

Iod Dip F 14 P

Authorisation number

EU-0018724-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

1,16

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

meta SPC 2

1.2.   Suffix to the authorisation number

Number

1-2

1.3.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

 

 

2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

 

Active Substance

7553-56-2

231-442-4

0

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

1,56

2,5

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

0

2.2.   Type(s) of formulation of the meta SPC 2

Formulation

AL — Any other liquid

 

 

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

Avoid release to the environment.

Dispose of contents to local/regional/national/international regulation.

Dispose of container to local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description

Table 3. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual dipping using a dip cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.1.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 4. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated dipping

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.2.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.2.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures: Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

Dip es Io-film

Dip es Io-film 3.0

Iod-Dip Io-film 30

Authorisation number

EU-0018724-0002 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

2,5

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier

meta SPC 3

1.2.   Suffix to the authorisation number

Number

1-3

1.3.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

 

 

2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

 

Active Substance

7553-56-2

231-442-4

0

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

1,56

4,16

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

0

2.2.   Type(s) of formulation of the meta SPC 3

Formulation

AL — Any other liquid

 

 

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

Avoid release to the environment.

Dispose of contents to local/regional/national/international regulation.

Dispose of container to local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description

Table 5. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual dipping using a dip cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.1.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 6. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated dipping

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.2.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.2.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures: Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

Dip es barriere S

Dip es barriere 3.0

Iod-Dip F 30 P

Baktostop Barier color

Authorisation number

EU-0018724-0003 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

2,5

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

7.2.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

Dip es barriere RS

Dip es barriere 5.0

Iod-Dip F 50 P

BaktoStop barier

Authorisation number

EU-0018724-0004 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

4,16

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier

meta SPC 4

1.2.   Suffix to the authorisation number

Number

1-4

1.3.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

 

 

2.   META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

 

Active Substance

7553-56-2

231-442-4

0

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

1,56

2,5

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

0

2.2.   Type(s) of formulation of the meta SPC 4

Formulation

AL — Any other liquid

 

 

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

Avoid release to the environment.

Dispose of contents to local/regional/national/international regulation.

Dispose of container to local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 4

4.1.   Use description

Table 7. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual dipping using a dip cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.1.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 8. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using a trigger sprayer

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual spraying using a trigger sprayer

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.2.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the top of the trigger sprayer on it. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, spray the disinfectant on the teats using the trigger sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Refill the reservoir of the trigger sprayer with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water.

4.2.2.   Use-specific risk mitigation measures

Use chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) during postmilking teat disinfection by manual spraying using a trigger sprayer.

Avoid working in a spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.3.   Use description

Table 9. Use # 3 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using an electronic sprayer

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual spraying using an electronic sprayer

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.3.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product assuming 5 mL product per cow and insert a sucking lance of the electronic sprayer. Avoid discharge of surplus fluids.

Clean carefully the teats by wiping with a single service paper towel/cloth before milking.

After milking, spray the disinfectant on the teats using the electronic sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Replace the empty can by a new can containing the RTU product as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, put the sucking lance system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.

4.3.2.   Use-specific risk mitigation measures

Use chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) during postmilking teat disinfection by manual spraying using an electronic sprayer.

Avoid working in spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.4.   Use description

Table 10. Use # 4 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated dipping

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.4.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.4.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.5.   Use description

Table 11. Use # 5 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated spraying by robot

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated spraying by robot

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.5.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the robotic milking device. Avoid discharge of surplus fluids.

The teats are cleaned by robot with automatic brushes.

After robotic milking, the disinfectant is sprayed automatically onto teats from a cluster arm.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Rinsing of the sprayer is automatic.

4.5.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures:

Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

Dip es silver

Authorisation number

EU-0018724-0005 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

2,5

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

Identifier

meta SPC 5

1.2.   Suffix to the authorisation number

Number

1-5

1.3.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

 

 

2.   META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

 

Active Substance

7553-56-2

231-442-4

0

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

1,16

1,16

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

0

2.2.   Type(s) of formulation of the meta SPC 5

Formulation

AL — Any other liquid

 

 

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements

 

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

4.   AUTHORISED USE(S) OF THE META SPC 5

4.1.   Use description

Table 12. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual dipping using a dip cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.1.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 13. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using a trigger sprayer

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual spraying using a trigger sprayer

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.2.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the top of the trigger sprayer on it. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, spray the disinfectant on the teats using the trigger sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Refill the reservoir of the trigger sprayer with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water.

4.2.2.   Use-specific risk mitigation measures

Avoid working in a spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.3.   Use description

Table 14. Use # 3 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using an electronic sprayer

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual spraying using an electronic sprayer

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.3.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product assuming 5 mL product per cow and insert a sucking lance of the electronic sprayer. Avoid discharge of surplus fluids.

Clean carefully the teats by wiping with a single service paper towel/cloth before milking.

After milking, spray the disinfectant on the teats using the electronic sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Replace the empty can by a new can containing the RTU product as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, put the sucking lance system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.

4.3.2.   Use-specific risk mitigation measures

Avoid working in a spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.4.   Use description

Table 15. Use # 4 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated dipping

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.4.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.4.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.5.   Use description

Table 16. Use # 5 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated spraying by robot

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated spraying by robot

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.5.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the robotic milking device. Avoid discharge of surplus fluids.

The teats are cleaned by robot with automatic brushes.

After robotic milking, the disinfectant is sprayed automatically onto teats from a cluster arm.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Rinsing of the sprayer is automatic.

4.5.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures: Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

Dip es SF

Dip es SF 3.0

Iod Dip S 30 P

Dip es SF 1.4

Iod-Dip S 14 P

EUTADIPP

Authorisation number

EU-0018724-0006 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

1,16

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

Identifier

meta SPC 6

1.2.   Suffix to the authorisation number

Number

1-6

1.3.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

 

 

2.   META SPC 6 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 6

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

 

Active Substance

7553-56-2

231-442-4

0

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

1,16

1,16

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

0

2.2.   Type(s) of formulation of the meta SPC 6

Formulation

AL — Any other liquid

 

 

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements

 

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

4.   AUTHORISED USE(S) OF THE META SPC 6

4.1.   Use description

Table 17. Use # 1 — Teat disinfection of milkable animals: Pre-milking teat disinfection by manual foaming

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use before milking

Application method(s)

Manual foaming using a foam cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Pre-milking application: 2-3×/day (before each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.1.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the foam cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth before pre-milking disinfection.

Before milking, squeeze the reservoir and put the foam cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Leave the product on the teats for at least 60 seconds.

Refill the cup of the foaming unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After disinfection, empty the reservoir and clean reservoir and foam cup by rinsing with water.

4.1.2.   Use-specific risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 18. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual foaming

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual foaming using a foam cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.2.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the foam cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the foam cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the foaming unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and foam cup by rinsing with water.

4.2.2.   Use-specific risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.3.   Use description

Table 19. Use # 3 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated foaming

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria-

Yeasts-

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated foaming

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2 - 3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.3.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated foaming-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat disinfectant is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of foam when the teat foam cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated foaming-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.3.2.   Use-specific risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.4.   Use description

Table 20. Use # 4 — Teat disinfection of milkable animals: Pre- and post-milking teat disinfection by manual foaming

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use before and after milking

Application method(s)

Manual foaming using a foam cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Pre- and post-milking application: 4-6 times per day (before and after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.4.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the foam cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth before pre-milking disinfection.

Before milking, squeeze the reservoir and put the foam cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Leave the product on the teats for at least 60 seconds.

Clean the teats carefully by wiping with a cloth immediately before milking. After milking, repeat the disinfection by foaming as described above.

Refill the cup of the foaming unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and foam cup by rinsing with water.

4.4.2.   Use-specific risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures:

Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

Dip es Io-foam

Dip es Io-foam 1.4

Iod-Dip Io-foam

BaktoStop foam

Authorisation number

EU-0018724-0007 1-6

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

1,16

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0

META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier

Identifier

meta SPC 7

1.2.   Suffix to the authorisation number

Number

1-7

1.3.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

 

 

2.   META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

 

Active Substance

7553-56-2

231-442-4

0,14

0,14

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

0

0

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0,11

0,33

2.2.   Type(s) of formulation of the meta SPC 7

Formulation

AL — Any other liquid

 

 

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

Avoid release to the environment.

Dispose of contents to local/regional/national/international regulation.

Dispose of container to local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description

Table 21. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual dipping using a dip cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.1.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 22. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual foaming

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual foaming using a foam cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.2.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the foam cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the foam cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the foaming unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and foam cup by rinsing with water.

4.2.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.3.   Use description

Table 23. Use # 3 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using a trigger sprayer

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual spraying using a trigger sprayer

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.3.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the top of the trigger sprayer on it. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, spray the disinfectant on the teats using the trigger sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Refill the reservoir of the trigger sprayer with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water.

4.3.2.   Use-specific risk mitigation measures

Use chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) during postmilking teat disinfection by manual spraying using a trigger sprayer.

Avoid working in spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.4.   Use description

Table 24. Use # 4 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using an electronic sprayer

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual spraying using an electronic sprayer

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.4.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product assuming 5 mL product per cow and insert a sucking lance of the electronic sprayer. Avoid discharge of surplus fluids.

Clean carefully the teats by wiping with a single service paper towel/cloth before milking.

After milking, spray the disinfectant on the teats using the electronic sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Replace the empty can by a new can containing the RTU product as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, put the sucking lance system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.

4.4.2.   Use-specific risk mitigation measures

Use chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) during post/milking teat disinfection by manual spraying using an electronic sprayer.

Avoid working in spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.5.   Use description

Table 25. Use # 5 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated dipping

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.5.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.5.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.6.   Use description

Table 26. Use # 6 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated foaming

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated foaming

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.6.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated foaming-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat disinfectant is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of foam when the teat foam cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated foaming-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.6.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.6.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.6.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.6.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.7.   Use description

Table 27. Use # 7 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated spraying by robot

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated spraying by robot

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.7.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the robotic milking device. Avoid discharge of surplus fluids.

The teats are cleaned by robot with automatic brushes.

After robotic milking, the disinfectant is sprayed automatically onto teats from a cluster arm.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Rinsing of the sprayer is automatic.

4.7.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.7.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.7.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (7) OF THE META SPC 7

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Wash with water and soap.

After eye contact: Rinse opened eye for several minutes under running water. Then consult doctor.

After swallowing: Rinse out mouth and then drink plenty of water. Seek immediate medical advice.

Stability and reactivity

Possibility of hazardous reactions: Reaction with oxidant- and reducing agent.

Conditions to avoid: No further relevant information available.

Incompatible materials: No further relevant information available.

Hazardous decomposition products: iodine (when warming up).

Accidental release measures

Personal precautions, protective equipment and emergency procedures: No special measures required.

Environmental precautions: Do not allow product to reach sewage systems or water bodies in great quantities.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods

Recommendation: Must be specially treated with regard to official regulations.

Waste disposal key number: Corresponding to the regulation of the European Waste catalogue the relation of the waste key numbers has to be made specific to industry and process.

European waste catalogue: Corresponding to the regulation of the EWC the relation of the waste key numbers has to be made specific to industry and process.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if necessary with cleaning agent.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

calgodip D 1200

Jod-Dip S 12

Dip es SF 1200

Authorisation number

EU-0018724-0008 1-7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0,14

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

0

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0,15

META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier

Identifier

meta SPC 8

1.2.   Suffix to the authorisation number

Number

1-8

1.3.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

 

 

2.   META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

 

Active Substance

7553-56-2

231-442-4

0,14

0,54

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

0

0

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0,11

0,33

2.2.   Type(s) of formulation of the meta SPC 8

Formulation

AL — Any other liquid

 

 

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

Avoid release to the environment.

Dispose of contents to local/regional/national/international regulation.

Dispose of container to local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 8

4.1.   Use description

Table 28. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual dipping using a dip cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.1.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 29. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated dipping

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.2.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.2.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (8) OF THE META SPC 8

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Wash with water and soap. If skin irritation continues, consult a doctor.

After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.

After swallowing: Rinse out mouth and then drink plenty of water. Seek medical treatment.

Stability and reactivity

Reactivity: No further relevant information available.

Chemical stability/thermal decomposition/conditions to be avoided: No decomposition if used according to specifications.

Possibility of hazardous reactions: No dangerous reactions known.

Conditions to avoid: No further relevant information available.

Incompatible materials: No further relevant information available.

Hazardous decomposition products: iodine (when warming up).

Accidental release measures

Personal precautions, protective equipment and emergency procedures: No special measures required.

Environmental precautions: Do not allow product to reach sewage systems or water bodies in great quantities.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binder). Do not use combustible material like sawdust. Dispose of the material collected according to regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods

Recommendation: Must be specially treated with regard to official regulations.

Waste disposal key number: Corresponding to the regulation of the European Waste catalogue the relation of the waste key numbers has to be made specific to industry and process.

European waste catalogue: Corresponding to the regulation of the EWC the relation of the waste key numbers has to be made specific to industry and process.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

calgodip D 3000 Film

Jod-Dip F 30

Jod Dipp 30 Film (Technolit)

Jod 30 Film (Iwetec)

Dip es barriere 3000

Lerapur Dip Jod 30

BaktoStop barrier color 3.0

Authorisation number

EU-0018724-0009 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0,34

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

0

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0,26

7.2.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

calgodip D 5000

Jod Dip F 50

Jod Dipp 50 (Iwetec)

Jod-Dipp 50 (Technolit)

Dip es barriere 5000

BaktoStop barrier 5.0

Authorisation number

EU-0018724-0010 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0,54

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

0

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0,26

META SPC 9

1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier

Identifier

meta SPC 9

1.2.   Suffix to the authorisation number

Number

1-9

1.3.   Product type(s)

Product type(s)

PT03 — Veterinary hygiene (Disinfectants)

 

 

2.   META SPC 9 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Iodine

 

Active Substance

7553-56-2

231-442-4

0,34

0,34

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

0

0

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0,11

0,33

2.2.   Type(s) of formulation of the meta SPC 9

Formulation

AL — Any other liquid

 

 

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

Hazard statements

Harmful to aquatic life with long lasting effects.

Precautionary statements

Avoid release to the environment.

Dispose of contents to local/regional/national/international regulation.

Dispose of container to local/regional/national/international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 9

4.1.   Use description

Table 30. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual dipping using a dip cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.1.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking. After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 31. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual foaming

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual foaming using a foam cup

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.2.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the foam cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the foam cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the foaming unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and foam cup by rinsing with water.

4.2.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.3.   Use description

Table 32. Use # 3 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using a trigger sprayer

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual spraying using a trigger sprayer

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.3.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the top of the trigger sprayer on it. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, spray the disinfectant on the teats using the trigger sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Refill the reservoir of the trigger sprayer with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water.

4.3.2.   Use-specific risk mitigation measures

Use chemical resistant gloves (glove material to be specified by the authorisation holder within the product information), coverall and chemical resistant boots during post-milking teat disinfection by manual spraying using a trigger sprayer.

Avoid working in spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.4.   Use description

Table 33. Use # 4 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using an electronic sprayer

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Manual spraying using an electronic sprayer

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.4.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product assuming 5 mL product per cow and insert a sucking lance of the electronic sprayer. Avoid discharge of surplus fluids.

Clean carefully the teats by wiping with a single service paper towel/cloth before milking.

After milking, spray the disinfectant on the teats using the electronic sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Replace the empty can by a new can containing the RTU product as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, put the sucking lance system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.

4.4.2.   Use-specific risk mitigation measures

Use chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) during post-milking teat disinfection by manual spraying using an electronic sprayer.

Avoid working in spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.5.   Use description

Table 34. Use # 5 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated dipping

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.5.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.5.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.6.   Use description

Table 35. Use # 6 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated foaming

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated foaming

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.6.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the automated foaming-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat disinfectant is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of foam when the teat foam cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated foaming-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.6.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.6.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.6.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.6.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.7.   Use description

Table 36. Use # 7 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated spraying by robot

Product Type

PT03 — Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Teat disinfection for milkable animals (dairy cows) for use after milking

Application method(s)

Automated spraying by robot

Application rate(s) and frequency

Cows: 5 mL per treatment

Post-milking application: 2-3×/day (after each milking)

Category(ies) of users

Professional

Pack sizes and packaging material

Jerrycan (HDPE): 5 – 60 kg

Drum (HDPE): 60 – 200 kg

IBC (HDPE): 600 – 1 000 kg

4.7.1.   Use-specific instructions for use

The product must be brought to a temperature above 20 °C before use.

Open a can containing the RTU product and insert a suction tube of the robotic milking device. Avoid discharge of surplus fluids.

The teats are cleaned by robot with automatic brushes.

After robotic milking, the disinfectant is sprayed automatically onto teats from a cluster arm.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Rinsing of the sprayer is automatic.

4.7.2.   Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.7.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.7.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (9) OF THE META SPC 9

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

See use specific risk mitigation measures.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Wash with water and soap.

After eye contact: Rinse opened eye for several minutes under running water. Then consult doctor.

After swallowing: Rinse out mouth and then drink plenty of water. Seek immediate medical advice.

Stability and reactivity

Possibility of hazardous reactions: Reaction with oxidant- and reducing agent.

Conditions to avoid: No further relevant information available.

Incompatible materials: No further relevant information available.

Hazardous decomposition products: iodine (when warming up).

Accidental release measures

Personal precautions, protective equipment and emergency procedures: No special measures required.

Environmental precautions: Do not allow product to reach sewage systems or water bodies in great quantities.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods

Recommendation: Must be specially treated with regard to official regulations.

Waste disposal key number: Corresponding to the regulation of the European Waste catalogue the relation of the waste key numbers has to be made specific to industry and process.

European waste catalogue: Corresponding to the regulation of the EWC the relation of the waste key numbers has to be made specific to industry and process.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if necessary with cleaning agent.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

6.   OTHER INFORMATION

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)

calgodip D 3000

Jod-Dip S 30

Bestfarm Dip Premium

Jod 30 Universal (Iwetec)

Jod-Dipp 30 (Technolit)

Dip es SF 3000

Lerapur Jod SP 30

Authorisation number

EU-0018724-0011 1-9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Iodine

 

Active Substance

7553-56-2

231-442-4

0,34

Polyvinylpyrrolidone iodine

 

Active Substance

25655-41-8

 

0

Acetic acid

Acetic acid

Non active substance

64-19-7

200-580-7

0,26


(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.

(6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC6.

(7)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC7.

(8)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC8.

(9)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC9.


DECISIONS

28.11.2018   

EN

Official Journal of the European Union

L 302/73


COMMISSION IMPLEMENTING DECISION (EU) 2018/1854

of 27 November 2018

on recognition of the ‘Better Biomass’ voluntary scheme for demonstrating compliance with the sustainability criteria under Directives 98/70/EC and 2009/28/EC of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (1), and in particular the second subparagraph of Article 7c(4) thereof,

Having regard to Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (2), and in particular the second subparagraph of Article 18(4) thereof,

Whereas:

(1)

Articles 7b and 7c of, and Annex IV to, Directive 98/70/EC and Articles 17 and 18 of, and Annex V to, Directive 2009/28/EC lay down similar sustainability criteria for biofuels and bioliquids, and similar procedures for verifying that biofuels and bioliquids comply with those criteria.

(2)

Where biofuels and bioliquids are to be taken into account for the purposes referred to in Article 17(1)(a), (b) and (c) of Directive 2009/28/EC, Member States should require economic operators to show that biofuels and bioliquids comply with the sustainability criteria set out in Article 17(2) to (5) of that Directive.

(3)

The Commission may decide that voluntary national or international schemes setting standards for the production of biomass products contain accurate data for the purposes of Article 17(2) of Directive 2009/28/EC, and/or demonstrate that consignments of biofuel or bioliquid comply with the sustainability criteria set out in Article 17(3), (4) and (5), and/or that no materials have been intentionally modified or discarded so that the consignment or part thereof would fall under Annex IX. Where an economic operator provides proof or data obtained in accordance with a voluntary scheme that has been recognised by the Commission, to the extent covered by the recognition decision, a Member State should not require the supplier to provide further evidence of compliance with the sustainability criteria.

(4)

The request for recognition that the ‘Better Biomass’ voluntary scheme demonstrates that consignments of biofuel comply with the sustainability criteria set out in Directives 98/70/EC and 2009/28/EC was submitted to the Commission on 20 February 2018. The scheme that is based in Vlinderweg 6, NL-2623 AX Delft, The Netherlands, covers a wide range of feedstocks including wastes and residues and the entire chain of custody. The recognised scheme documents should be made available at the transparency platform established under Directive 2009/28/EC.

(5)

In assessing the ‘Better Biomass’ voluntary scheme, the Commission found that it covers adequately the sustainability criteria set out in Directives 98/70/EC and 2009/28/EC, as well as applies a mass balance methodology in accordance with the requirements of Article 7c(1) of Directive 98/70/EC and Article 18(1) of Directive 2009/28/EC.

(6)

The assessment of the ‘Better Biomass’ voluntary scheme found that it meets adequate standards of reliability, transparency and independent auditing and also complies with the methodological requirements set out in Annex IV to Directive 98/70/EC and in Annex V to Directive 2009/28/EC.

(7)

The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels and Bioliquids,

HAS ADOPTED THIS DECISION:

Article 1

The ‘Better Biomass’ voluntary scheme (‘the scheme’), submitted for recognition to the Commission on 20 February 2018, demonstrates that consignments of biofuels and bioliquids produced in accordance with the standards for the production of biofuels and bioliquids set in the scheme comply with the sustainability criteria laid down in Article 7b(3), (4) and (5) of Directive 98/70/EC and Article 17(3), (4) and (5) of Directive 2009/28/EC.

The scheme also contains accurate data for the purposes of Article 17(2) of Directive 2009/28/EC and Article 7b(2) of Directive 98/70/EC.

Article 2

In the event that the contents of the scheme, as submitted for recognition to the Commission on 20 February 2018, change in a way that might affect the basis of this Decision, such changes shall be notified to the Commission without delay. The Commission shall assess the notified changes with a view to establishing whether the scheme still adequately covers the sustainability criteria for which it is recognised.

Article 3

The Commission may repeal this Decision inter alia under the following circumstances:

(a)

if it has been clearly demonstrated that the scheme has not implemented elements considered to be decisive for this Decision or if severe and structural breach of those elements has taken place;

(b)

if the scheme fails to submit annual reports to the Commission pursuant to Article 7c(6) of Directive 98/70/EC and Article 18(6) of Directive 2009/28/EC;

(c)

if the scheme fails to implement standards of independent auditing specified in implementing acts referred to in the third subparagraph of Article 7c(5) of Directive 98/70/EC and the third subparagraph of Article 18(5) of Directive 2009/28/EC or improvements to other elements of the scheme considered to be decisive for a continued recognition.

Article 4

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply until 18 December 2023.

Done at Brussels, 27 November 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 350, 28.12.1998, p. 58.

(2)  OJ L 140, 5.6.2009, p. 16.


28.11.2018   

EN

Official Journal of the European Union

L 302/75


COMMISSION IMPLEMENTING DECISION (EU) 2018/1855

of 27 November 2018

on greenhouse gas emissions covered by Decision No 406/2009/EC of the European Parliament and of the Council for the year 2016 for each Member State

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 525/2013 of the European Parliament and of the Council of 21 May 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change and repealing Decision No 280/2004/EC (1), and in particular Article 19(6) thereof,

Whereas:

(1)

Decision No 406/2009/EC of the European Parliament and of the Council (2) lays down annual emission allocations for each Member State for each year of the period 2013 to 2020 and a mechanism to annually assess compliance with those limits. Member States' annual emission allocations expressed in tonnes of CO2 equivalent are contained in Commission Decision 2013/162/EU (3). The adjustments to the annual emission allocations for each Member State are set in Commission Implementing Decision 2013/634/EU (4).

(2)

Article 19 of Regulation (EU) No 525/2013 provides for a procedure for the review of Member States' greenhouse gas (GHG) emissions inventories for the purpose of assessing compliance with Decision No 406/2009/EC. The annual review referred to in Article 19(2) of Regulation (EU) No 525/2013 was carried out on the basis of the 2016 emissions data reported to the Commission in March 2018 in accordance with the procedures laid down in Chapter III of Commission Implementing Regulation (EU) No 749/2014 (5) and Annex XVI to that Regulation.

(3)

The total amount of GHG emissions covered by Decision No 406/2009/EC for the year 2016 for each Member State should take into consideration the technical corrections and revised estimates calculated during the annual review as contained in the final review reports drawn up pursuant to Article 35(2) of Regulation (EU) No 749/2014.

(4)

This Decision should enter into force on the day of its publication in order to be aligned with the provisions of Article 19(7) of Regulation (EU) No 525/2013 which sets the date of publication of this Decision as the starting point for the four-month period when Member States are allowed to use the flexibility mechanisms under Decision No 406/2009/EC,

HAS ADOPTED THIS DECISION:

Article 1

The total sum of greenhouse gas emissions covered by Decision No 406/2009/EC for each Member State for the year 2016 arising from the corrected inventory data upon completion of the annual review referred to in Article 19(2) of Regulation (EU) No 525/2013 is set out in the Annex to this Decision.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

Done at Brussels, 27 November 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 165, 18.6.2013, p. 13.

(2)  Decision No 406/2009/EC of the European Parliament and of the Council of 23 April 2009 on the effort of Member States to reduce their greenhouse gas emissions to meet the Community's greenhouse gas emission reduction commitments up to 2020 (OJ L 140, 5.6.2009, p. 136).

(3)  Commission Decision 2013/162/EU of 26 March 2013 on determining Member States' annual emission allocations for the period from 2013 to 2020 pursuant to Decision No 406/2009/EC of the European Parliament and of the Council (OJ L 90, 28.3.2013, p. 106).

(4)  Commission Implementing Decision 2013/634/EU of 31 October 2013 on the adjustments to Member States' annual emission allocations for the period from 2013 to 2020 pursuant to Decision No 406/2009/EC of the European Parliament and of the Council (OJ L 292, 1.11.2013, p. 19).

(5)  Commission Implementing Regulation (EU) No 749/2014 of 30 June 2014 on structure, format, submission processes and review of information reported by Member States pursuant to Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 203, 11.7.2014, p. 23).


ANNEX

Member State

Greenhouse gas emissions for the year 2016 covered by Decision No 406/2009/EC

(tonnes of carbon dioxide equivalent)

Belgium

74 063 149

Bulgaria

25 587 947

Czech Republic

62 816 957

Denmark

33 124 678

Germany

454 157 411

Estonia

6 218 046

Ireland

43 798 177

Greece

44 897 200

Spain

198 472 205

France

351 924 668

Croatia

16 006 813

Italy

270 685 435

Cyprus

4 111 441

Latvia

9 107 440

Lithuania

13 921 700

Luxembourg

8 524 455

Hungary

42 059 940

Malta

1 329 995

Netherlands

101 333 437

Austria

50 618 898

Poland

198 664 758

Portugal

41 572 594

Romania

73 123 042

Slovenia

11 236 888

Slovakia

19 758 694

Finland

31 358 144

Sweden

32 612 247

United Kingdom

333 899 779


28.11.2018   

EN

Official Journal of the European Union

L 302/78


COMMISSION IMPLEMENTING DECISION (EU) 2018/1856

of 27 November 2018

amending the Annex to Implementing Decision 2014/709/EU concerning animal health control measures relating to African swine fever in certain Member States

(notified under document C(2018) 8058)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (1), and in particular Article 9(4) thereof,

Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary checks applicable in intra-Union trade in certain live animals and products with a view to the completion of the internal market (2), and in particular Article 10(4) thereof,

Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (3), and in particular Article 4(3) thereof,

Whereas:

(1)

Commission Implementing Decision 2014/709/EU (4) lays down animal health control measures in relation to African swine fever in certain Member States, where there have been confirmed cases of that disease in domestic or feral pigs (the Member States concerned). The Annex to that Implementing Decision demarcates and lists certain areas of the Member States concerned in Parts I to IV thereof, differentiated by the level of risk based on the epidemiological situation as regards that disease. The Annex to Implementing Decision 2014/709/EU has been amended several times to take account of changes in the epidemiological situation in the Union as regards African swine fever that need to be reflected in that Annex. The Annex to Implementing Decision 2014/709/EU was last amended by Commission Implementing Decision (EU) 2018/1689 (5), following recent instances of African swine fever in Poland and Romania.

(2)

The risk of the spread of African swine fever in wildlife is linked to the natural slow spread of that disease among feral pig populations, and also the risks linked to human activity, as demonstrated by the recent epidemiological evolution of that disease in the Union, and as documented by the European Food Safety Authority (EFSA) in the Scientific Opinion of the Panel on Animal Health and Welfare, published on 14 July 2015; in the Scientific Report of EFSA on Epidemiological analyses on African swine fever in the Baltic countries and Poland, published on 23 March 2017; and in the Scientific Report of EFSA on Epidemiological analyses of African swine fever in the Baltic States and Poland, published on 8 November 2017 (6).

(3)

Council Directive 2002/60/EC (7) lays down the minimum Union measures to be taken for the control of African swine fever. In particular, Article 9 of Directive 2002/60/EC provides for the establishment of a protection and a surveillance zone when African swine fever has been officially confirmed in pigs on a holding, and Articles 10 and 11 of that Directive lay down the measures to be taken in the protection and surveillance zones in order to prevent the spread of that disease. In addition, Article 15 of Directive 2002/60/EC provides for the measures to be taken where African swine fever is confirmed in feral pigs, including the placing under official surveillance of pig holdings in the defined infected area. Recent experience has shown that the measures laid down in Directive 2002/60/EC are effective in controlling the spread of that disease, and in particular the measures providing for the cleaning and disinfecting of infected holdings.

(4)

Taking into account the effectiveness of the measures being applied in the Member States in accordance with Directive 2002/60/EC, and in particular those laid down in Article 10(4)(b), Article 10(5) and Article 15 thereof, and in line with the risk mitigation measures for African swine fever set out in the Terrestrial Animal Health Code of the World Organization for Animal Health, certain areas in Latvia, Lithuania and Poland currently listed in Part III of the Annex to Implementing Decision 2014/709/EU should now be listed in Part II of that Annex, in view of the expiry of the period of three months from the date of the final cleaning and disinfection of the infected holdings. Given that Part III of the Annex to Implementing Decision 2014/709/EU lists the areas where the epidemiological situation is still evolving and very dynamic, when any amendments are made to areas listed in that Part, particular consideration must always be given to the effect on the surrounding areas.

(5)

In September 2018, a number of cases of African swine fever in wild boar were observed in Belgium. Commission Implementing Decisions (EU) 2018/1242 (8) and (EU) 2018/1281 (9) were adopted in response to those cases. Implementing Decision (EU) 2018/1281 repealed and replaced Implementing Decision (EU) 2018/1242 and it applies until 30 November 2018. Implementing Decision (EU) 2018/1281 provides that the infected area established by Belgium, where the measures provided for in Article 15 of Directive 2002/60/EC apply, are to comprise at least the areas listed in the Annex to that Implementing Decision.

(6)

These recent cases of African swine fever in Belgium constitute an increased level of risk which should be reflected in the Annex to Implementing Decision 2014/709/EU. Accordingly, this area of Belgium in the Ardennes region affected by African swine fever should now be listed in Part II of that Annex.

(7)

In addition, since the date of adoption of Implementing Decision (EU) 2018/1689, there have been further instances of African swine fever in other Member States that also need to be reflected in the Annex to Implementing Decision 2014/709/EU.

(8)

In October 2018, one case of African swine fever in a feral pig was observed in the county of Marijampolė in Lithuania. This case of African swine fever in a feral pig constitutes an increased level of risk which should be reflected in the Annex to Implementing Decision 2014/709/EU. Accordingly, this area of Lithuania affected by African swine fever should now be listed in Part II of that Annex instead of in Part I thereof.

(9)

In October and November 2018, a few cases of African swine fever in feral pigs were observed in the county of Liepaja in Latvia in close proximity to an area listed in Part I of the Annex to Implementing Decision 2014/709/EU. These cases of African swine fever in feral pigs constitute an increased level of risk which should be reflected in that Annex. Accordingly, these areas of Latvia affected by African swine fever should be listed in Part II of the Annex to Implementing Decision 2014/709/EU instead of in Part I thereof.

(10)

In October and November 2018, a few cases of African swine fever in feral pigs were observed in the counties of Krasnystaw and Garwolin in Poland in close proximity to areas listed in Part I of the Annex to Implementing Decision 2014/709/EU. These cases of African swine fever in feral pigs constitute an increased level of risk which should be reflected in that Annex. Accordingly, these areas of Poland affected by African swine fever should be listed in Part II of the Annex to Implementing Decision 2014/709/EU instead of in Part I thereof.

(11)

In October and November 2018, a few cases of African swine fever in feral pigs were observed in the county of Borsod-Abaúj-Zemplén in Hungary in close proximity to an area listed in Part I of the Annex to Implementing Decision 2014/709/EU. These cases of African swine fever in feral pigs constitute an increased level of risk which should be reflected in that Annex. Accordingly, these areas of Hungary affected by African swine fever should now be listed in Part II of the Annex to Implementing Decision 2014/709/EU instead of in Part I thereof.

(12)

In order to take account of recent developments in the epidemiological evolution of African swine fever in the Union, and in order to combat the risks associated with the spread of that disease in a proactive manner, new high-risk areas of a sufficient size should be demarcated for Belgium, Lithuania, Latvia, Poland and Hungary and duly listed in Parts I, II and III of the Annex to Implementing Decision 2014/709/EU. The Annex to Implementing Decision 2014/709/EU should therefore be amended accordingly.

(13)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION:

Article 1

The Annex to Implementing Decision 2014/709/EU is replaced by the text set out in the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 27 November 2018.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission


(1)  OJ L 395, 30.12.1989, p. 13.

(2)  OJ L 224, 18.8.1990, p. 29.

(3)  OJ L 18, 23.1.2003, p. 11.

(4)  Commission Implementing Decision 2014/709/EU of 9 October 2014 concerning animal health control measures relating to African swine fever in certain Member States and repealing Implementing Decision 2014/178/EU (OJ L 295, 11.10.2014, p. 63).

(5)  Commission Implementing Decision (EU) 2018/1689 of 8 November 2018 amending the Annex to Implementing Decision 2014/709/EU concerning animal health control measures relating to African swine fever in certain Member States (OJ L 279, 9.11.2018, p. 39).

(6)  EFSA Journal 2015;13(7):4163; EFSA Journal 2017;15(3):4732; EFSA Journal 2017;15(11):5068.

(7)  Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever (OJ L 192, 20.7.2002, p. 27).

(8)  Commission Implementing Decision (EU) 2018/1242 of 14 September 2018 concerning certain interim protective measures relating to African swine fever in Belgium (OJ L 231I, 14.9.2018, p. 1).

(9)  Commission Implementing Decision (EU) 2018/1281 of 21 September 2018 concerning certain protective measures relating to African swine fever in Belgium (OJ L 239, 24.9.2018, p. 18).


ANNEX

The Annex to Implementing Decision 2014/709/EU is replaced by the following:

‘ANNEX

PART I

1.   Belgium

The following areas in Belgium:

in Luxembourg province:

the area is delimited at the outside clockwise by:

the border with France,

N85: Rue de Carignan, Rue de France, Rue des Généraux Cuvelier, Rue de la Station, Rue de Neufchâteau,

N894: Rue de Chiny, Rue de la Fontenelle, Rue du Millénaire, Rue de la Goulette, Pont saint Nicolas, Rue des Combattants, Rue du Pré au bois,

N801: Rue Notre-Dame,

N894: Rue des Combattants, Rue des Tilleuls, Naleumont, Rue de Rindchay, Rue de la Distillerie,

N40: Rue de Luxembourg, Rue Ranci, Rue de la Chapelle,

Rue du Tombois,

Rue Du Pierroy,

Rue Saint-Orban,

Rue Saint-Aubain,

Rue des Cottages,

Rue de Relune,

Rue de Rulune,

Route de l'Ermitage,

N87: Route de Habay,

Chemin des Ecoliers,

Le Routy,

Rue Burgknapp,

Rue de la Halte,

Rue du Centre,

Rue de l'Eglise,

Rue du Marquisat,

Rue de la Carrière,

Rue de la Lorraine,

Rue du Beynert,

Millewée,

Rue du Tram,

Millewée,

N4: Route de Bastogne, Avenue de Longwy, Route de Luxembourg,

the border with the Grand Duchy of Luxembourg,

the area is delimited at the outside clockwise by:

La N88, depuis son intersection avec la N883 au niveau d'Aubange jusque son intersection avec la N891 au niveau de Gérouville,

La N891 jusque son intersection avec la N83 au niveau de Jamoigne,

La N83 jusque son intersection avec la N891,

La N891 jusque son intersection avec la N879 au niveau de Marbehan,

La N879 jusque son intersection avec la N897 au niveau de Marbehan,

La N897 jusque son intersection avec la E25 - E411,

La E25 - E411 jusque son intersection avec la N81 au niveau de Weyler,

La N81 jusque son intersection avec la N883 au niveau d'Aubange,

La N883 jusque son intersection avec la N88.

2.   Bulgaria

The following areas in Bulgaria:

in Silistra region:

within municipality of Alfatar:

Bistra,

Alekovo,

within municipality of Dulovo:

Kolobar,

Varbina,

Kozyak,

Mezhden,

Chukovetz,

Tzar Asen,

Cherkovna,

Dulovo,

Chernik,

Poroyno,

Vodno,

Chernolik,

within municipality of Sitovo:

Sitovo,

Yastrebno,

Slatina,

within municipality of Silistra:

Bradvari,

Zlatoklas,

Yordanovo,

Profesor Ishirkovo,

Kazimir,

Babuk,

Sarpovo,

Smiletz,

Tzenovich,

Polkovnik Lambrinovo,

Srebarna,

Aydemir,

Silistra,

Kalipetrovo,

in Dobrich region:

within municipality of General Toshevo:

Rosen,

Krasen,

Zhiten,

Snop,

Gradini,

within municipality of Krushari:

Severnyak,

Abrit,

Dobrin,

Alexandria,

Polkovnik Dyakovo,

Zagortzi,

Krushartzi,

Bistretz,

Telerig,

Lozenetz,

within municipality of Tervel:

Onogur,

Balik,

Аngelariy,

Sarnetz,

Bozhan,

Popgruevo,

Kochmar,

Guslar,

Mali Izvor,

Тervel,

Bonevo,

Voynikovo,

Bezmer,

Chestimensko,

Profesor Zlatarski,

Kableshkovo,

Glavantzi,

Nova kamena,

Kladentzi,

Gradnitza,

within municipality of Dobrich:

Kragulevo,

Dobrevo,

Cherna,

Pchelnik,

Zhitnitza,

Polkovnik Ivanovo,

Hitovo,

Vodnyantzi,

Feldfebel Denkovo (Dyankovo),

Podslon,

Geshanovo.

3.   The Czech Republic

The following areas in the Czech Republic:

okres Uherské Hradiště,

okres Kroměříž,

okres Vsetín,

katastrální území obcí v okrese Zlín:

Bělov,

Biskupice u Luhačovic,

Bohuslavice nad Vláří,

Brumov,

Bylnice,

Divnice,

Dobrkovice,

Dolní Lhota u Luhačovic,

Drnovice u Valašských Klobouk,

Halenkovice,

Haluzice,

Hrádek na Vlárské dráze,

Hřivínův Újezd,

Jestřabí nad Vláří,

Kaňovice u Luhačovic,

Kelníky,

Kladná-Žilín,

Kochavec,

Komárov u Napajedel,

Křekov,

Lipina,

Lipová u Slavičína,

Ludkovice,

Luhačovice,

Machová,

Mirošov u Valašských Klobouk,

Mysločovice,

Napajedla,

Návojná,

Nedašov,

Nedašova Lhota,

Nevšová,

Otrokovice,

Petrůvka u Slavičína,

Pohořelice u Napajedel,

Polichno,

Popov nad Vláří,

Poteč,

Pozlovice,

Rokytnice u Slavičína,

Rudimov,

Řetechov,

Sazovice,

Sidonie,

Slavičín,

Smolina,

Spytihněv,

Svatý Štěpán,

Šanov,

Šarovy,

Štítná nad Vláří,

Tichov,

Tlumačov na Moravě,

Valašské Klobouky,

Velký Ořechov,

Vlachova Lhota,

Vlachovice,

Vrbětice,

Žlutava.

4.   Estonia

The following areas in Estonia:

Hiiu maakond.

5.   Hungary

The following areas in Hungary:

Borsod-Abaúj-Zemplén megye 650100, 650200, 650300, 650400, 650500, 650600, 650700, 650800, 650900, 651000, 651100, 651200, 651300, 651400, 651500, 651610, 651700, 651801, 651802, 651803, 651900, 652000, 652100, 652200, 652300, 652400, 652500, 652601, 652602, 652603, 652700, 652800, 652900, 653000, 653100, 653200, 653300, 653401, 653403, 653500, 653600, 653700, 653800, 653900, 654000, 654201, 654202, 654301, 654302, 654400, 654501, 654502, 654600, 654700, 654800, 654900, 655000, 655100, 655200, 655300, 655400, 655500, 655600, 655700, 655800, 655901, 655902, 656000, 656100, 656200, 656300, 656400, 656600, 657300, 657400, 657500, 657600, 657700, 657800, 657900, 658000, 658100, 658201, 658202, 658403, 659210, 659220, 659300, 659400, 659500, 659601, 659602, 659901, 660000, 660100, 660200, 660400, 660501, 660502, és 660600 kódszámú vadgazdálkodási egységeinek teljes területe,

Hajdú-Bihar megye 900150, 900250, 900350, 900450, 900550, 900650, 900660, 900670, 900750, 900850, 900860, 900930, 900950, 901050, 901150, 901250, 901260, 901270, 901350, 901450, 901551, 901560, 901570, 901580, 901590, 901650, 901660, 901850, 901950, 902050, 902850, 902860, 902950, 902960, 903050, 903150, 903250, 903350, 903360, 903370, 903450, 903550, 904450, 904460, 904550, 904650, 904750, 904760, 905450 és 905550 kódszámú vadgazdálkodási egységeinek teljes területe,

Heves megye 700150, 700250, 700260, 700350, 700450, 700460, 700550, 700650, 700750, 700850, 702350, 702450, 702550, 702750, 702850, 703350, 703360, 703450, 703550, 703610, 703750, 703850, 703950, 704050, 704150, 704250, 704350, 704450, 704550, 704650, 704750, 704850, 704950, 705050, 705250, 705350, 705510 és 705610 kódszámú vadgazdálkodási egységeinek teljes területe,

Jász-Nagykun-Szolnok megye 750150, 750160, 750250, 750260, 750350, 750450, 750460, 750550, 750650, 750750, 750850, 750950 és 750960 kódszámú vadgazdálkodási egységeinek teljes területe,

Nógrád megye 550120, 550130, 550210, 550710, 550810, 551450, 551460, 551550, 551650, 551710, 552010, 552150, 552250, 552350, 552360, 552450, 552460, 552520, 552550, 552610, 552620, 552710, 552850, 552860, 552950, 552960, 552970, 553050, 553110, 553250, 553260, 553350, 553650, 553750, 553850, 553910és 554050 kódszámú vadgazdálkodási egységeinek teljes területe,

Pest megye 571250, 571350, 571550, 571610, 571750, 571760, 572250, 572350, 572550, 572850, 572950, 573360, 573450, 580050 és 580450 kódszámú vadgazdálkodási egységeinek teljes területe,

Szabolcs-Szatmár-Bereg megye 850650, 850850, 851851, 851852, 851950, 852350, 852450, 852550, 852750, 853560, 853650, 853751, 853850, 853950, 853960, 854050, 854150, 854250, 854350, 855250, 855350, 855450, 855460, 855550, 855650, 855660, 855750, 855850, 855950, 855960, 856012, 856050, 856150, 856260, 857050, 857150, 857350 és 857450 kódszámú vadgazdálkodási egységeinek teljes területe.

6.   Latvia

The following areas in Latvia:

Aizputes novads,

Alsungas novads,

Kuldīgas novada Gudenieku, Turlavas un Laidu pagasts,

Pāvilostas novada Sakas pagasts un Pāvilostas pilsēta,

Priekules novada Bunkas, Virgas un Kalētu pagasts,

Skrundas novada Rudbāržu pagasts,

Stopiņu novada daļa, kas atrodas uz rietumiem no autoceļa V36, P4 un P5, Acones ielas, Dauguļupes ielas un Dauguļupītes,

Ventspils novada Jūrkalnes pagasts,

Grobiņas novada Bārtas un Gaviezes pagasts,

Rucavas novada Dunikas pagasts.

7.   Lithuania

The following areas in Lithuania:

Jurbarko rajono savivaldybė: Smalininkų ir Viešvilės seniūnijos,

Kelmės rajono savivaldybė: Kelmės, Kelmės apylinkių, Kražių, Kukečių, Liolių, Pakražančio seniūnijos, Tytyvėnų seniūnijos dalis į vakarus ir šiaurę nuo kelio Nr. 157 ir į vakarus nuo kelio Nr. 2105 ir Tytuvėnų apylinkių seniūnijos dalis į šiaurę nuo kelio Nr. 157 ir į vakarus nuo kelio Nr. 2105, ir Vaiguvos seniūnijos,

Mažeikių rajono savivaldybė: Sedos, Šerkšnėnų ir Židikų seniūnijos,

Pagėgių savivaldybė,

Plungės rajono savivaldybė,

Raseinių rajono savivaldybė: Girkalnio ir Kalnūjų seniūnijos dalis į šiaurę nuo kelio Nr A1, Nemakščių, Paliepių, Raseinių, Raseinių miesto ir Viduklės seniūnijos,

Rietavo savivaldybė,

Šakių rajono savivaldybė: Barzdų, Griškabūdžio, Kriūkų, Kudirkos Naumiesčio, Lekėčių, Sintautų, Slavikų, Sudargo ir Žvirgždaičių seniūnijos,

Šilalės rajono savivalybė,

Šilutės rajono savivaldybė: Juknaičių, Kintų, Šilutės ir Usėnų seniūnijos,

Tauragės rajono savivaldybė: Lauksargių, Skaudvilės, Tauragės, Mažonų, Tauragės miesto ir Žygaičių seniūnijos.

8.   Poland

The following areas in Poland:

w województwie warmińsko-mazurskim:

gmina Stare Juchy w powiecie ełckim,

gmina Dubeninki w powiecie gołdapskim,

gmina Ruciane – Nida i część gminy Pisz położona na południe od linii wyznaczonej przez drogę nr 58 oraz miasto Pisz w powiecie piskim,

powiat giżycki,

gminy Mikołajki, Piecki, część gminy Sorkwity położona na południe od drogi nr 16 i część gminy wiejskiej Mrągowo położona na południe od linii wyznaczonej przez drogę nr 16 biegnącą od zachodniej granicy gminy do granicy miasta Mrągowo oraz na południe od linii wyznaczonej przez drogę nr 59 biegnącą od wschodniej granicy gminy do granicy miasta Mrągowo w powiecie mrągowskim,

gmina Bisztynek w powiecie bartoszyckim,

gminy Dźwierzuty i Świętajno w powiecie szczycieńskim.

gminy Lubomino, część gminy Orneta położona na zachód od linii wyznaczonej przez linię kolejową łącząca miejscowości Lubomino i Pieniężno, część gminy wiejskiej Lidzbark Warmiński położona na południe od linii wyznaczonej przez drogę nr 513 biegnącą od wschodniej granicy gminy do wschodniej granicy miasta Lidzbark Warmiński oraz na południowy wschód od linii wyznaczonej przez drogę nr 51 i część gminy Kiwity położona na południe od linii wyznaczonej przez drogę nr 513 w powiecie lidzbarskim,

gminy Elbląg, Godkowo, Gronowo Elbląskie, Markusy, Pasłęk i część gminy Tolkmicko niewymieniona w części II załącznika w powiecie elbląskim oraz strefa wód przybrzeżnych Zalewu Wiślanego i Zatoki Elbląskiej,

powiat miejski Elbląg,

gminy Biskupiec, Dobre Miasto, Jeziorany, Kolno i Świątki w powiecie olsztyńskim,

gmina Miłakowo w powiecie ostródzkim,

w województwie podlaskim:

gminy Brańsk z miastem Brańsk, Rudka i Wyszki w powiecie bielskim,

gmina Perlejewo w powiecie siemiatyckim,

gminy Kolno z miastem Kolno, Mały Płock i Turośl w powiecie kolneńskim,

gmina Poświętne w powiecie białostockim,

gminy Kołaki Kościelne, Rutki, Szumowo, część gminy Zambrów położona na południe od linii wyznaczonej przez drogę nr S8 i miasto Zambrów w powiecie zambrowskim,

gminy Wiżajny i Przerośl w powiecie suwalskim,

gminy Kulesze Kościelne, Nowe Piekuty, Szepietowo, Klukowo, Ciechanowiec, Wysokie Mazowieckie z miastem Wysokie Mazowieckie, Czyżew w powiecie wysokomazowieckim,

gminy Miastkowo, Nowogród i Zbójna w powiecie łomżyńskim.

w województwie mazowieckim:

gminy Ceranów, Kosów Lacki, Sabnie, Sterdyń, część gminy Bielany położona na zachód od linii wyznaczonej przez drogę nr 63 i część gminy wiejskiej Sokołów Podlaski położona na zachód od linii wyznaczonej przez drogę nr 63 w powiecie sokołowskim,

gminy Grębków, Korytnica, Liw, Łochów, Miedzna, Sadowne, Stoczek, Wierzbno i miasto Węgrów w powiecie węgrowskim,

część gminy Kotuń położona na zachód od linii wyznaczonej przez drogę łączącą miejscowości Nowa Dąbrówka, Pieróg, Kotuń wzdłuż ulicy Gorzkowskiego i Kolejowej do przejazdu kolejowego łączącego się z ulicą Siedlecką, Broszków, Żuków w powiecie siedleckim,

gminy Rzekuń, Troszyn, Lelis, Czerwin i Goworowo w powiecie ostrołęckim,

powiat miejski Ostrołęka,

powiat ostrowski,

gminy Karniewo, Maków Mazowiecki, Rzewnie i Szelków w powiecie makowskim,

gmina Krasne w powiecie przasnyskim,

gminy Mała Wieś i Wyszogród w powiecie płockim,

gminy Ciechanów z miastem Ciechanów, Glinojeck, Gołymin – Ośrodek, Ojrzeń, Opinogóra Górna i Sońsk w powiecie ciechanowskim,

gminy Baboszewo, Czerwińsk nad Wisłą, Naruszewo, Płońsk z miastem Płońsk, Sochocin i Załuski w powiecie płońskim,

gminy Gzy, Obryte, Zatory, Pułtusk i część gminy Winnica położona na wschód od linii wyznaczonej przez drogę łączącą miejscowości Bielany, Winnica i Pokrzywnica w powiecie pułtuskim,

gminy Brańszczyk, Długosiodło, Rząśnik, Wyszków, Zabrodzie i część gminy Somianka położona na północ od linii wyznaczonej przez drogę nr 62 w powiecie wyszkowskim,

gminy Jadów, Klembów, Poświętne, Strachówka i Tłuszcz w powiecie wołomińskim,

gminy Dobre, Jakubów, Mrozy, Kałuszyn, Stanisławów, część gminy Cegłów położona na północ od linii wyznaczonej przez drogę biegnącą od zachodniej granicy gminy łączącą miejscowości Wiciejów, Mienia, Cegłów i na wschód od linii wyznaczonej przez drogę łączącą miejscowości Cegłów, Skwarne i Podskwarne biegnącą do wschodniej granicy gminy i część gminy Mińsk Mazowiecki położona na północ od linii wyznaczonej przez drogę nr 92 biegnącą od zachodniej granicy gminy do granicy miasta Mińsk Mazowiecki i na północ od linii wyznaczonej przez drogę biegnącą od wschodniej granicy miasta Mińsk Mazowiecki łączącą miejscowości Targówka, Budy Barcząckie do wschodniej granicy gminy w powiecie mińskim,

gminy Górzno, Łaskarzew z miastem Łaskarzew, Sobolew, Trojanów, Żelechów i część gminy Miastków Kościelny położona na południe od rzeki Wilga w powiecie garwolińskim,

gminy Garbatka Letnisko, Gniewoszów i Sieciechów w powiecie kozienickim,

gminy Baranów i Jaktorów w powiecie grodziskim,

powiat żyrardowski,

gminy Belsk Duży, Błędów, Goszczyn i Mogielnica w powiecie grójeckim,

gminy Białobrzegi, Promna, Stara Błotnica, Wyśmierzyce i część gminy Stromiec położona na południe od linii wyznaczonej przez drogę nr 48 w powiecie białobrzeskim,

gminy Jedlińsk, Jastrzębia i Pionki z miastem Pionki w powiecie radomskim,

gminy Iłów, Młodzieszyn, Nowa Sucha, Rybno, Sochaczew z miastem Sochaczew i Teresin w powiecie sochaczewskim,

gmina Policzna w powiecie zwoleńskim,

gmina Solec nad Wisłą w powiecie lipskim.

w województwie lubelskim:

gminy Bełżyce, Borzechów, Niedrzwica Duża, Jabłonna, Krzczonów, Jastków, Konopnica, Wólka, Głusk, Strzyżewice i Wojciechów w powiecie lubelskim,

gminy Miączyn, Nielisz, Sitno, Stary Zamość, Komarów-Osada i część gminy wiejskiej Zamość położona na północ od linii wyznaczonej przez drogę nr 74 w powiecie zamojskim,

powiat miejski Zamość,

gminy Trzeszczany i Werbkowice w powiecie hrubieszowskim,

gminy Jeziorzany i Kock w powiecie lubartowskim,

gminy Adamów i Serokomla w powiecie łukowskim,

powiat rycki,

gminy Janowiec, i część gminy wiejskiej Puławy położona na zachód od rzeki Wisły w powiecie puławskim,

gminy Chodel, Karczmiska, Łaziska, Opole Lubelskie, Poniatowa i Wilków w powiecie opolskim,

gminy Mełgiew, Rybczewice, miasto Świdnik i część gminy Piaski położona na południe od linii wyznaczonej przez drogę nr 17 biegnącą od wschodniej granicy gminy Piaski do skrzyżowania z drogą nr S12 i na zachód od linii wyznaczonej przez drogę biegnącą od skrzyżowania dróg nr 17 i nr S12 przez miejscowość Majdan Brzezicki do północnej granicy gminy w powiecie świdnickim;

gminy Gorzków, Rudnik i Żółkiewka w powiecie krasnostawskim,

gminy Bełżec, Jarczów, Lubycza Królewska, Łaszczów, Susiec, Tyszowce i Ulhówek w powiecie tomaszowskim,

gminy Łukowa i Obsza w powiecie biłgorajskim,

powiat miejski Lublin,

gminy Kraśnik z miastem Kraśnik, Szastarka, Trzydnik Duży, Urzędów, Wilkołaz i Zakrzówek w powiecie kraśnickim,

gminy Modliborzyce i Potok Wielki w powiecie janowskim.

w województwie podkarpackim:

gminy Horyniec-Zdrój, Narol, Stary Dzików, Wielkie Oczy i część gminy Oleszyce położona na południe od linii wyznaczonej przez drogę biegnącą od wschodniej granicy gminy przez miejscowość Borchów do skrzyżowania z drogą nr 865 w miejscowości Oleszyce, a następnie na zachód od linii wyznaczonej przez drogę nr 865 biegnącą w kierunku północno-wschodnim do skrzyżowania z drogą biegnąca w kierunku północno-zachodnim przez miejscowość Lubomierz - na południe od linii wyznaczonej przez tę drogę do skrzyżowania z drogą łączącą miejscowości Uszkowce i Nowy Dzików – na zachód od tej drogi w powiecie lubaczowskim,

gminy Laszki i Wiązownica w powiecie jarosławskim,

gminy Pysznica, Zaleszany i miasto Stalowa Wola w powiecie stalowowolskim,

gmina Gorzyce w powiecie tarnobrzeskim.

w województwie świętokrzyskim:

gminy Tarłów i Ożarów w powiecie opatowskim,

gminy Dwikozy, Zawichost i miasto Sandomierz w powiecie sandomierskim.

9.   Romania

The following areas in Romania:

Județul Alba cu următoarea delimitare:

La nord de drumul național nr. 7,

Județul Arad cu următoarea delimitare:

La nord de linia descrisă de următoarele localități:

Macea,

Șiria,

Bârzava,

Toc, care se află la joncțiunea cu drumul național nr. 7,

La nord de drumul național nr. 7,

Restul județului Argeș care nu a fost inclus în partea III,

Județul Bistrița,

Județul Brașov,

Județul Cluj,

Județul Covasna,

Județul Harghita,

Județul Hunedoara cu următoarea delimitare:

La nord de linia descrisă de următoarele localități:

Brănișca,

Municipiul Deva,

Turdaș,

Localitățile Zam și Aurel Vlaicu, care se află la joncțiunea cu drumul național nr. 7,

La nord de drumul național nr. 7,

Județul Iași,

Județul Neamț,

Județul Vâlcea,

Județul Bistrița Nasaud,

Restul județului Maramureș care nu a fost inclus în Partea III cu următoarele comune:

Comuna Vișeu de Sus,

Comuna Borșa,

Comuna Oarța de Jos,

Comuna Suciu de Sus,

Comuna Moisei,

Comuna Coroieni,

Comuna Târgu Lăpuș,

Comuna Vima Mică,

Comuna Boiu Mare,

Comuna Valea Chioarului,

Comuna Ulmeni,

Comuna Băsești,

Comuna Baia Mare,

Comuna Tăuții Magherăuș,

Comuna Cicărlău,

Comuna Seini,

Comuna Ardusat,

Comuna Farcasa,

Comuna Salsig,

Comuna Asuaju de Sus,

Comuna Băița de sub Codru,

Comuna Bicaz,

Comuna Grosi,

Comuna Recea,

Comuna Baia Sprie,

Comuna Sisesti,

Comuna Cernesti,

Copalnic Mănăstur,

Comuna Dumbrăvița,

Comuna Cupseni,

Comuna Șomcuța Mare,

Comuna Sacaleșeni,

Comuna Remetea Chioarului,

Comuna Mireșu Mare,

Comuna Ariniș.

Restul județului Mehedinți care nu a fost inclus în Partea III cu următoarele comune:

Comuna Garla Mare,

Hinova,

Burila Mare,

Gruia,

Pristol,

Dubova,

Municipiul Drobeta Turnu Severin,

Eselnița,

Salcia,

Devesel,

Svinița,

Gogoșu,

Simian,

Orșova,

Obârșia Closani,

Baia de Aramă,

Bala,

Florești,

Broșteni,

Corcova,

Isverna,

Balta,

Podeni,

Cireșu,

Ilovița,

Ponoarele,

Ilovăț,

Patulele,

Jiana,

Iyvoru Bârzii,

Malovat,

Bălvănești,

Breznița Ocol,

Godeanu,

Padina Mare,

Corlățel,

Vânju Mare,

Vânjuleț,

Obârșia de Câmp,

Vânători,

Vladaia,

Punghina,

Cujmir,

Oprișor,

Dârvari,

Căzănești,

Husnicioara,

Poroina Mare,

Prunișor,

Tămna,

Livezile,

Rogova,

Voloiac,

Sisești,

Sovarna,

Bălăcița,

Județul Gorj.

PART II

1.   Belgium

The following areas in Belgium:

in Luxembourg province:

the area is delimited clockwise by:

La N88, depuis son intersection avec la N883 au niveau d'Aubange jusque son intersection avec la N891 au niveau de Gérouville,

La N891 jusque son intersection avec la N83 au niveau de Jamoigne,

La N83 jusque son intersection avec la N891,

La N891 jusque son intersection avec la N879 au niveau de Marbehan,

La N879 jusque son intersection avec la N897 au niveau de Marbehan,

La N897 jusque son intersection avec la E25 - E411,

La E25 - E411 jusque son intersection avec la N81 au niveau de Weyler,

La N81 jusque son intersection avec la N883 au niveau d'Aubange,

La N883 jusque son intersection avec la N88.

2.   Bulgaria

The following areas in Bulgaria:

in Silistra region:

within municipality of Kaynardzha:

Voynovo,

Kaynardzha,

Kranovo,

Zarnik,

Dobrudzhanka,

Golesh,

Svetoslav,

Polk. Cholakovo,

Kamentzi,

Gospodinovo,

Sredishte,

Strelkovo,

Poprusanovo,

Posev,

within municipality of Alfatar:

Alfatar,

Kutlovitza,

Vasil Levski,

within municipality of Silistra:

Glavan,

Popkralevo,

Bogorovo,