# Official Journal L 133/2020

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 133 |
| | |
| English edition | Legislation | Volume 6328 April 2020 |

ISSN 1977-0677

Official Journal

of the European Union

L 133

English edition

Legislation

Volume 6328 April 2020

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2020/578 of 21 February 2020 amending Regulation (EU) 2018/196 of the European Parliament and of the Council on additional customs duties on imports of certain products originating in the United States of America | 1 |
| | * | Commission Implementing Regulation (EU) 2020/579 of 27 April 2020 granting a Union authorisation for the biocidal product family HYPRED’s octanoic acid based products (
  1
  ) | 4 |
| | * | Commission Implementing Regulation (EU) 2020/580 of 27 April 2020 granting a Union authorisation for the biocidal product family SOPURCLEAN (
  1
  ) | 23 |
| | * | Commission Implementing Regulation (EU) 2020/581 of 27 April 2020 amending Implementing Regulation (EU) 2018/659 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (
  1
  ) | 52 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2020/578 of 21 February 2020 amending Regulation (EU) 2018/196 of the European Parliament and of the Council on additional customs duties on imports of certain products originating in the United States of America

1

*

Commission Implementing Regulation (EU) 2020/579 of 27 April 2020 granting a Union authorisation for the biocidal product family HYPRED’s octanoic acid based products (
  1
  )

1

4

*

Commission Implementing Regulation (EU) 2020/580 of 27 April 2020 granting a Union authorisation for the biocidal product family SOPURCLEAN (
  1
  )

1

23

*

Commission Implementing Regulation (EU) 2020/581 of 27 April 2020 amending Implementing Regulation (EU) 2018/659 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (
  1
  )

1

52

| | |
| --- | --- |
| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| 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. |
| --- | --- |

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.

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II Non-legislative acts

REGULATIONS

| 28.4.2020 | EN | Official Journal of the European Union | L 133/1 |
| --- | --- | --- | --- |

28.4.2020

EN

Official Journal of the European Union

L 133/1

---

COMMISSION DELEGATED REGULATION (EU) 2020/578

of 21 February 2020

amending Regulation (EU) 2018/196 of the European Parliament and of the Council on additional customs duties on imports of certain products originating in the United States of America

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2018/196 of the European Parliament and of the Council of 7 February 2018 on additional customs duties on imports of certain products originating in the United States of America (1), and in particular Article 3(3) thereof,

Whereas:

| (1) | As a result of the United States’ failure to bring the Continued Dumping and Subsidy Offset Act (CDSOA) in compliance with its obligations under the World Trade Organization (WTO) agreements, Regulation (EU) 2018/196 originally imposed a 4,3 % ad valorem additional customs duty on imports of certain products originating in the United States of America. In conformity with the WTO authorisation to suspend the application of concessions to the United States, the Commission is to adjust the level of suspension annually to the level of nullification or impairment caused by the CDSOA to the European Union at that time. In 2019, the level of suspension was adjusted to 0,001 % ad valorem additional customs duty and Regulation (EU) 2018/196 was amended accordingly. |
| --- | --- |

(1)

As a result of the United States’ failure to bring the Continued Dumping and Subsidy Offset Act (CDSOA) in compliance with its obligations under the World Trade Organization (WTO) agreements, Regulation (EU) 2018/196 originally imposed a 4,3 % ad valorem additional customs duty on imports of certain products originating in the United States of America. In conformity with the WTO authorisation to suspend the application of concessions to the United States, the Commission is to adjust the level of suspension annually to the level of nullification or impairment caused by the CDSOA to the European Union at that time. In 2019, the level of suspension was adjusted to 0,001 % ad valorem additional customs duty and Regulation (EU) 2018/196 was amended accordingly.

| (2) | The CDSOA disbursements for the most recent year for which data are available relate to the distribution of anti-dumping and countervailing duties collected during the Fiscal Year 2019 (1 October 2018-30 September 2019). On the basis of the data published by the United States’ Customs and Border Protection and pursuant to Article 3(1)(a) of Regulation (EU) 2018/196, the level of nullification or impairment caused to the Union is calculated at USD 25 506,30. |
| --- | --- |

(2)

The CDSOA disbursements for the most recent year for which data are available relate to the distribution of anti-dumping and countervailing duties collected during the Fiscal Year 2019 (1 October 2018-30 September 2019). On the basis of the data published by the United States’ Customs and Border Protection and pursuant to Article 3(1)(a) of Regulation (EU) 2018/196, the level of nullification or impairment caused to the Union is calculated at USD 25 506,30.

| (3) | The level of nullification or impairment and consequently of suspension has increased compared to the 2019 level. However, the level of suspension cannot be adjusted to the level of nullification or impairment in accordance with Article 3(1)(c) by adding products to the list in Annex I to Regulation (EU) 2018/196, as all products from the list in Annex II to Regulation (EU) 2018/196 have already been added to Annex I. As a consequence, in accordance with Article 3(1)(e) of that Regulation, the Commission should keep the list of products in Annex I unchanged and amend the rate of the additional duty in order to adjust the level of suspension to the level of nullification or impairment. The four products listed in Annex I should therefore be maintained on the list and the rate of additional import duty should be amended and set at 0,012 %. |
| --- | --- |

(3)

The level of nullification or impairment and consequently of suspension has increased compared to the 2019 level. However, the level of suspension cannot be adjusted to the level of nullification or impairment in accordance with Article 3(1)(c) by adding products to the list in Annex I to Regulation (EU) 2018/196, as all products from the list in Annex II to Regulation (EU) 2018/196 have already been added to Annex I. As a consequence, in accordance with Article 3(1)(e) of that Regulation, the Commission should keep the list of products in Annex I unchanged and amend the rate of the additional duty in order to adjust the level of suspension to the level of nullification or impairment. The four products listed in Annex I should therefore be maintained on the list and the rate of additional import duty should be amended and set at 0,012 %.

| (4) | The effect of a 0,012 % ad valorem additional import duty on imports from the United States of the products in Annex I represents, over one year, a value of trade that does not exceed USD 25 506,30. |
| --- | --- |

(4)

The effect of a 0,012 % ad valorem additional import duty on imports from the United States of the products in Annex I represents, over one year, a value of trade that does not exceed USD 25 506,30.

| (5) | To make sure that there are no delays in the application of the amended rate of additional import duty, this Regulation should enter into force on the day of its publication. |
| --- | --- |

(5)

To make sure that there are no delays in the application of the amended rate of additional import duty, this Regulation should enter into force on the day of its publication.

| (6) | Regulation (EU) 2018/196 should therefore be amended accordingly, |
| --- | --- |

(6)

Regulation (EU) 2018/196 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Article 2 of Regulation (EU) 2018/196 is replaced by the following:

‘Article 2

An ad valorem duty of 0,012 % additional to the customs duty applicable under Regulation (EU) No 952/2013 of the European Parliament and of the Council (*1) shall be imposed on the products originating in the United States listed in Annex I to this Regulation.

Article 2

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

It shall apply from 1 May 2020.

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

Done at Brussels, 21 February 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 44, 16.2.2018, p. 1.

1

---

ANNEX

‘ANNEX I

The products on which additional import duties are to apply are identified by their eight-digit CN codes. The description of products classified under these codes can be found in Annex I to Council Regulation (EEC) No 2658/87 (1).

0710 40 00

ex 9003 19 00
  “frames and mountings of base metal”

8705 10 00

6204 62 31

---

(1)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).’

1

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| 28.4.2020 | EN | Official Journal of the European Union | L 133/4 |
| --- | --- | --- | --- |

28.4.2020

EN

Official Journal of the European Union

L 133/4

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/579

of 27 April 2020

granting a Union authorisation for the biocidal product family ‘HYPRED’s octanoic acid based products’

(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 the first subparagraph of Article 44(5) thereof,

Whereas:

| (1) | On 25 August 2015, HYPRED SAS, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘HYPRED‘s octanoic acid based products’ of product-type 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under the case number BC-LR019297-17 in the Register for Biocidal Products. |
| --- | --- |

(1)

On 25 August 2015, HYPRED SAS, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘HYPRED‘s octanoic acid based products’ of product-type 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under the case number BC-LR019297-17 in the Register for Biocidal Products.

| (2) | ‘HYPRED‘s octanoic acid based products’ contains octanoic acid, 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. |
| --- | --- |

(2)

‘HYPRED‘s octanoic acid based products’ contains octanoic acid, 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.

| (3) | On 19 December 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). |
| --- | --- |

(3)

On 19 December 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

| (4) | On 11 July 2019, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘HYPRED‘s octanoic acid based products’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 11 July 2019, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘HYPRED‘s octanoic acid based products’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

| (5) | The opinion concludes that ‘HYPRED‘s octanoic acid based products’ is a ‘biocidal product family’ within the meaning of 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, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
| --- | --- |

(5)

The opinion concludes that ‘HYPRED‘s octanoic acid based products’ is a ‘biocidal product family’ within the meaning of 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, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

| (6) | On 25 July 2019, 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)

On 25 July 2019, 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.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘HYPRED‘s octanoic acid based products’. |
| --- | --- |

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘HYPRED‘s octanoic acid based products’.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(8)

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 with authorisation number EU-0021020-0000 is granted to HYPRED SAS for the making available on the market and use of the biocidal product family ‘HYPRED‘s octanoic acid based products’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 18 May 2020 until 30 April 2030.

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 April 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  ECHA opinion of 26 June 2019 on the Union authorisation of ‘HYPRED‘s octanoic acid based products’ (ECHA/BPC/226/2019), https://echa.europa.eu/bpc-opinions-on-union-authorisation.

2

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ANNEX

Summary of product characteristics for a biocidal product family

HYPRED‘s octanoic acid based products

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0021020-0000

R4BP asset number: EU-0021020-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | HYPRED‘s octanoic acid based products |
| --- | --- |

Name

HYPRED‘s octanoic acid based products

1.2.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (Disinfectants)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | HYPRED SAS |
| --- | --- | --- |
| Address | 55 boulevard Jules Verger, 35803 DINARD, France |
| Authorisation number | EU-0021020-0000 |
| R4BP asset number | EU-0021020-0000 |
| Date of the authorisation | 18 May 2020 |
| Expiry date of the authorisation | 30 April 2030 |

Name and address of the authorisation holder

Name

HYPRED SAS

Address

55 boulevard Jules Verger, 35803 DINARD, France

Authorisation number

EU-0021020-0000

R4BP asset number

EU-0021020-0000

Date of the authorisation

18 May 2020

Expiry date of the authorisation

30 April 2030

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | HYPRED SAS |
| --- | --- |
| Address of manufacturer | 55 Boulevard Jules Verger, 35803 DINARD France |
| Location of manufacturing sites | HYPRED SAS – 55 Boulevard Jules Verger – BP 10180, 35803 DINARD France |
| HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4, 64320 buk Poland |
| HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C n° 32, 31160 Orcoyen – NAVARRA Spain |
| HYPRED GmbH Marie-Curie-Straße 23, 53332 Bornheim – Sechtem Germany |
| HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova, 26010 Ripalta Arpina CR Italy |
| AG France S.A.S – Zone Industrielle Le Roineau, 72500 Vaas France |
| Anti-Germ Austria GmbH – ‘Pfongauer Straße 17, 5202 Neumarkt am Wallersee’ Austria |
| Anti-Germ Deutschland GmbH – Oberbrühlstraße 16-18, 87700 Memmingen Germany |

Name of manufacturer

HYPRED SAS

Address of manufacturer

55 Boulevard Jules Verger, 35803 DINARD France

Location of manufacturing sites

HYPRED SAS – 55 Boulevard Jules Verger – BP 10180, 35803 DINARD France

HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4, 64320 buk Poland

HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C n° 32, 31160 Orcoyen – NAVARRA Spain

HYPRED GmbH Marie-Curie-Straße 23, 53332 Bornheim – Sechtem Germany

HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova, 26010 Ripalta Arpina CR Italy

AG France S.A.S – Zone Industrielle Le Roineau, 72500 Vaas France

Anti-Germ Austria GmbH – ‘Pfongauer Straße 17, 5202 Neumarkt am Wallersee’ Austria

Anti-Germ Deutschland GmbH – Oberbrühlstraße 16-18, 87700 Memmingen Germany

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

| Active substance | Octanoic acid |
| --- | --- |
| Name of manufacturer | Emery Oleochemicals (M) |
| Address of manufacturer | Sdn Bhd (63112-D), Lot 4, Jalan Perak, Kawasan Perusahaan, 42500 Telok Panglima Garang, Selangor Malaysia |
| Location of manufacturing sites | Sdn Bhd (63112-D), Lot 4, Jalan Perak, Kawasan Perusahaan, 42500 Telok Panglima Garang, Selangor Malaysia |

Active substance

Octanoic acid

Name of manufacturer

Emery Oleochemicals (M)

Address of manufacturer

Sdn Bhd (63112-D), Lot 4, Jalan Perak, Kawasan Perusahaan, 42500 Telok Panglima Garang, Selangor Malaysia

Location of manufacturing sites

Sdn Bhd (63112-D), Lot 4, Jalan Perak, Kawasan Perusahaan, 42500 Telok Panglima Garang, Selangor Malaysia

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 |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 3,0 | 10,0 |
| Methanesulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 0,0 | 21,0 |
| L-(+)-Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 0,0 | 17,6 |
| N,N-dimethyl-1-Decanamine, N-oxid | | Non-active substance | 2605-79-0 | 220-020-5 | 2,25 | 6,0 |
| Ethoxylated alcohol | Ethoxylated alcohol | Non-active substance | 31726-34-8 | 500-077-5 | 0,0 | 15,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Octanoic acid

Active Substance

124-07-2

204-677-5

3,0

10,0

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

0,0

21,0

L-(+)-Lactic acid

Non-active substance

79-33-4

201-196-2

0,0

17,6

N,N-dimethyl-1-Decanamine, N-oxid

Non-active substance

2605-79-0

220-020-5

2,25

6,0

Ethoxylated alcohol

Ethoxylated alcohol

Non-active substance

31726-34-8

500-077-5

0,0

15,0

2.2.   Type(s) of formulation

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

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 |
| --- | --- |

Identifier

Meta SPC 1

1.2.   Suffix to the authorisation number

| Number | 1-1 |
| --- | --- |

Number

1-1

1.3.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (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 |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 3,0 | 3,0 |
| Methanesulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 21,0 | 21,0 |
| L-(+)-Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 0,0 | 0,0 |
| N,N-dimethyl-1-Decanamine, N-oxid | | Non-active substance | 2605-79-0 | 220-020-5 | 2,25 | 2,25 |
| Ethoxylated alcohol | Ethoxylated alcohol | Non-active substance | 31726-34-8 | 500-077-5 | 5,0 | 5,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Octanoic acid

Active Substance

124-07-2

204-677-5

3,0

3,0

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

21,0

21,0

L-(+)-Lactic acid

Non-active substance

79-33-4

201-196-2

0,0

0,0

N,N-dimethyl-1-Decanamine, N-oxid

Non-active substance

2605-79-0

220-020-5

2,25

2,25

Ethoxylated alcohol

Ethoxylated alcohol

Non-active substance

31726-34-8

500-077-5

5,0

5,0

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

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | May be corrosive to metals.
  Causes severe skin burns and eye damage.
  May cause respiratory irritation.
  Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  Wear face protection.
  IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
  IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER.
  Dispose of contents according to local/regional/national/international regulation.
  Avoid release to the environment. |

Hazard statements

May be corrosive to metals.

Causes severe skin burns and eye damage.

May cause respiratory irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER.

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

Avoid release to the environment.

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

4.1.   Use description

Table 1. Use # 1 – Circulation in dairy industry

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  Cleaning – disinfection of circuits in dairy industry |
| Application method(s) | Closed system: Circulation
  Clean-in-place (CIP), circulation |
| Application rate(s) and frequency | - Use 1 % product solution for bactericidal activity and 1,5 % product solution for yeasticidal activity
  1 to 3 cycles per day, 208 to 360 days per year |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Opaque jerrycan High-density polyethylene (HDPE) 5L
  Opaque jerrycan HDPE 10L
  Opaque jerrycan HDPE 22L
  Opaque drum HDPE 60L
  Opaque drum HDPE 120L
  Opaque drum HDPE 220L
  Opaque container HDPE 640L
  Opaque container HDPE 1000L |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Cleaning – disinfection of circuits in dairy industry

Application method(s)

Closed system: Circulation

Clean-in-place (CIP), circulation

Application rate(s) and frequency

- Use 1 % product solution for bactericidal activity and 1,5 % product solution for yeasticidal activity

1 to 3 cycles per day, 208 to 360 days per year

Category(ies) of users

Professional

Pack sizes and packaging material

Opaque jerrycan High-density polyethylene (HDPE) 5L

Opaque jerrycan HDPE 10L

Opaque jerrycan HDPE 22L

Opaque drum HDPE 60L

Opaque drum HDPE 120L

Opaque drum HDPE 220L

Opaque container HDPE 640L

Opaque container HDPE 1000L

4.1.1.   Use-specific instructions for use

Rinse the circuits with drinking water before disinfection.

Apply the product by circulation.

Product concentration and contact time:

| — | 1 % bactericidal in 5 minutes |
| --- | --- |

—

1 % bactericidal in 5 minutes

| — | 1,5 % yeasticidal in 15 minutes |
| --- | --- |

—

1,5 % yeasticidal in 15 minutes

Temperature of the product solution: 40 – 85 °C

Rinse with drinking water.

4.1.2.   Use-specific risk mitigation measures

See general directions for use

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 – Circulation in farms

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  Cleaning – disinfection of milking equipment and milking robots in farms |
| Application method(s) | Closed system: Circulation |
| Application rate(s) and frequency | - Use 0,8 % product solution for bactericidal activity and 1,5 % product solution for yeasticidal activity.
  The milk installations cleaned and disinfected twice a day and the milk tank is cleaned and disinfected once every three days. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Opaque jerrycan HDPE 5L
  Opaque jerrycan HDPE 10L
  Opaque jerrycan HDPE 22L
  Opaque drum HDPE 60L
  Opaque drum HDPE 120L
  Opaque drum HDPE 220L
  Opaque container HDPE 640L
  Opaque container HDPE 1000L |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Cleaning – disinfection of milking equipment and milking robots in farms

Application method(s)

Closed system: Circulation

Application rate(s) and frequency

- Use 0,8 % product solution for bactericidal activity and 1,5 % product solution for yeasticidal activity.

The milk installations cleaned and disinfected twice a day and the milk tank is cleaned and disinfected once every three days.

Category(ies) of users

Professional

Pack sizes and packaging material

Opaque jerrycan HDPE 5L

Opaque jerrycan HDPE 10L

Opaque jerrycan HDPE 22L

Opaque drum HDPE 60L

Opaque drum HDPE 120L

Opaque drum HDPE 220L

Opaque container HDPE 640L

Opaque container HDPE 1000L

4.2.1.   Use-specific instructions for use

Milk installations with or without a programmer.

| (1) | After milking, rinse the equipment with warm drinking water. |
| --- | --- |

(1)

After milking, rinse the equipment with warm drinking water.

| (2) | Apply the solution by circulation at an initial recommended temperature of 60 °C minimum to achieve a final temperature of 40– 45 °C. |
| --- | --- |

(2)

Apply the solution by circulation at an initial recommended temperature of 60 °C minimum to achieve a final temperature of 40– 45 °C.

Product concentration and contact time:

| | 0,8 % bactericidal in 10 minutes |
| --- | --- |

0,8 % bactericidal in 10 minutes

| | 1,5 % yeasticidal in 15 minutes |
| --- | --- |

1,5 % yeasticidal in 15 minutes

Do not use at temperature above 75 °C.

| 3) | Rinse with cold drinking water. |
| --- | --- |

3)

Rinse with cold drinking water.

Use the product twice a day or once a day when alternating with another product.

When alternating, use an alternative cleaner-disinfectant or a cleaning product 1 to 4 times per week depending on the temperature reached in the system.

Contact your supplier for choosing the alternative product and the frequency of use.

Do not mix the product with an alkaline or chlorinated alkaline product.

4.2.2.   Use-specific risk mitigation measures

See general directions for use

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

| — | Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information). |
| --- | --- |

—

Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).

| — | Ensure adequate ventilation during the application. |
| --- | --- |

—

Ensure adequate ventilation during the application.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID

| — | IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.

| — | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.

| — | IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.

| — | IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.

See Safety Data Sheets. They contain an emergency phone number

When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

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

Do not discharge the product directly to sewer or to the environment.

Dispose the product and its packaging in accordance with applicable local and national regulations.

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

Shelf-life: 2 years in HDPE

Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.

6.   OTHER INFORMATION

The cleaning properties of the product has not been assessed as they are not covered by Regulation (EU) No 528/2012.

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) | HYPRACID ONE
  DEPTACID BD
  prevides®MS |
| --- | --- |
| Authorisation number | EU-0021020-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 3,0 |
| Methanesulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 21,0 |
| N,N-dimethyl-1-Decanamine, N-oxid | | Non-active substance | 2605-79-0 | 220-020-5 | 2,25 |
| Ethoxylated alcohol | Ethoxylated alcohol | Non-active substance | 31726-34-8 | 500-077-5 | 5,0 |

Trade name(s)

HYPRACID ONE

DEPTACID BD

prevides®MS

Authorisation number

EU-0021020-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

3,0

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

21,0

N,N-dimethyl-1-Decanamine, N-oxid

Non-active substance

2605-79-0

220-020-5

2,25

Ethoxylated alcohol

Ethoxylated alcohol

Non-active substance

31726-34-8

500-077-5

5,0

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | Meta SPC 2 |
| --- | --- |

Identifier

Meta SPC 2

1.2.   Suffix to the authorisation number

| Number | 1-2 |
| --- | --- |

Number

1-2

1.3.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (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 |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 10,0 | 10,0 |
| Methanesulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 14,0 | 14,0 |
| L-(+)-Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 0,0 | 0,0 |
| N,N-dimethyl-1-Decanamine, N-oxid | | Non-active substance | 2605-79-0 | 220-020-5 | 4,5 | 4,5 |
| Ethoxylated alcohol | Ethoxylated alcohol | Non-active substance | 31726-34-8 | 500-077-5 | 15,0 | 15,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Octanoic acid

Active Substance

124-07-2

204-677-5

10,0

10,0

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

14,0

14,0

L-(+)-Lactic acid

Non-active substance

79-33-4

201-196-2

0,0

0,0

N,N-dimethyl-1-Decanamine, N-oxid

Non-active substance

2605-79-0

220-020-5

4,5

4,5

Ethoxylated alcohol

Ethoxylated alcohol

Non-active substance

31726-34-8

500-077-5

15,0

15,0

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

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | May be corrosive to metals.
  Harmful if swallowed.
  Causes severe skin burns and eye damage.
  Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  Wear face protection.
  IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
  IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER.
  Dispose of contents according to local/regional/national/international regulation.
  Avoid release to the environment. |

Hazard statements

May be corrosive to metals.

Harmful if swallowed.

Causes severe skin burns and eye damage.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER.

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

Avoid release to the environment.

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

4.1.   Use description

Table 3. Use # 1 – Circulation

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  Disinfection of circuits in breweries, dairy and beverage industries |
| Application method(s) | Closed system: Circulation
  CIP, circulation |
| Application rate(s) and frequency | - Use 0,4 % product solution for bactericidal activity and 0,6 % product solution for yeasticidal activity.
  1 to 3 cycles per day, 208 to 360 days per year |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Opaque jerrycan HDPE 5L
  Opaque jerrycan HDPE 10L
  Opaque jerrycan HDPE 22L
  Opaque drum HDPE 60L
  Opaque drum HDPE 120L
  Opaque drum HDPE 220L
  Opaque container HDPE 640L
  Opaque container HDPE 1000L |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Disinfection of circuits in breweries, dairy and beverage industries

Application method(s)

Closed system: Circulation

CIP, circulation

Application rate(s) and frequency

- Use 0,4 % product solution for bactericidal activity and 0,6 % product solution for yeasticidal activity.

1 to 3 cycles per day, 208 to 360 days per year

Category(ies) of users

Professional

Pack sizes and packaging material

Opaque jerrycan HDPE 5L

Opaque jerrycan HDPE 10L

Opaque jerrycan HDPE 22L

Opaque drum HDPE 60L

Opaque drum HDPE 120L

Opaque drum HDPE 220L

Opaque container HDPE 640L

Opaque container HDPE 1000L

4.1.1.   Use-specific instructions for use

See general directions for use

4.1.2.   Use-specific risk mitigation measures

See general directions for use

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

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

5.1.   Instructions for use

Prior to the application of the product, clean with a detergent and rinse with drinking water.

Apply the product by circulation.

Product concentration and contact time:

| — | 0,4 % bactericidal in 5 minutes |
| --- | --- |

—

0,4 % bactericidal in 5 minutes

| — | 0,6 % yeasticidal in 15 minutes |
| --- | --- |

—

0,6 % yeasticidal in 15 minutes

Temperature of the product solution: 20 – 85 °C

Rinse with drinking water.

5.2.   Risk mitigation measures

| — | Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information). |
| --- | --- |

—

Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).

| — | Ensure adequate ventilation during the application. |
| --- | --- |

—

Ensure adequate ventilation during the application.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID

| — | IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.

| — | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.

| — | IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.

| — | IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.

See Safety Data Sheets. They contain an emergency phone number.

When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

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

Do not discharge the product directly to sewer or to the environment.

Dispose the product and its packaging in accordance with applicable local and national regulations.

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

Shelf-life: 2 years in HDPE

Conditions of storage: keep only in the original packaging. Keep container closed. Keep in a cool place. Do not store at temperature above 40 °C.

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) | DEPTACID CCB |
| --- | --- |
| Authorisation number | EU-0021020-0002 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 10,0 |
| Methanesulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 14,0 |
| N,N-dimethyl-1-Decanamine, N-oxid | | Non-active substance | 2605-79-0 | 220-020-5 | 4,5 |
| Ethoxylated alcohol | Ethoxylated alcohol | Non-active substance | 31726-34-8 | 500-077-5 | 15,0 |

Trade name(s)

DEPTACID CCB

Authorisation number

EU-0021020-0002 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

10,0

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

14,0

N,N-dimethyl-1-Decanamine, N-oxid

Non-active substance

2605-79-0

220-020-5

4,5

Ethoxylated alcohol

Ethoxylated alcohol

Non-active substance

31726-34-8

500-077-5

15,0

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

| Identifier | Meta SPC 3 |
| --- | --- |

Identifier

Meta SPC 3

1.2.   Suffix to the authorisation number

| Number | 1-3 |
| --- | --- |

Number

1-3

1.3.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (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 |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 10,0 | 10,0 |
| Methanesulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 0,0 | 0,0 |
| L-(+)-Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 17,6 | 17,6 |
| N,N-dimethyl-1-Decanamine, N-oxid | | Non-active substance | 2605-79-0 | 220-020-5 | 6,0 | 6,0 |
| Ethoxylated alcohol | Ethoxylated alcohol | Non-active substance | 31726-34-8 | 500-077-5 | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Octanoic acid

Active Substance

124-07-2

204-677-5

10,0

10,0

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

0,0

0,0

L-(+)-Lactic acid

Non-active substance

79-33-4

201-196-2

17,6

17,6

N,N-dimethyl-1-Decanamine, N-oxid

Non-active substance

2605-79-0

220-020-5

6,0

6,0

Ethoxylated alcohol

Ethoxylated alcohol

Non-active substance

31726-34-8

500-077-5

0,0

0,0

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

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

| Hazard statements | May be corrosive to metals.
  Causes severe skin burns and eye damage.
  Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  Wear face protection.
  IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
  IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER.
  Dispose of contents according to local/regional/national/international regulation.
  Avoid release to the environment. |

Hazard statements

May be corrosive to metals.

Causes severe skin burns and eye damage.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER.

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

Avoid release to the environment.

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

4.1.   Use description

Table 4. Use # 1 – Circulation

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  Disinfection of circuits in breweries, dairy and beverage industries |
| Application method(s) | Closed system: Circulation
  CIP, circulation |
| Application rate(s) and frequency | - Use 0,4 % product solution
  1 to 3 cycles per day, 208 to 360 days per year |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Opaque jerrycan HDPE 5L
  Opaque jerrycan HDPE 10L
  Opaque jerrycan HDPE 22L
  Opaque drum HDPE 60L
  Opaque drum HDPE 120L
  Opaque drum HDPE 220L
  Opaque container HDPE 640L
  Opaque container HDPE 1000L |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Disinfection of circuits in breweries, dairy and beverage industries

Application method(s)

Closed system: Circulation

CIP, circulation

Application rate(s) and frequency

- Use 0,4 % product solution

1 to 3 cycles per day, 208 to 360 days per year

Category(ies) of users

Professional

Pack sizes and packaging material

Opaque jerrycan HDPE 5L

Opaque jerrycan HDPE 10L

Opaque jerrycan HDPE 22L

Opaque drum HDPE 60L

Opaque drum HDPE 120L

Opaque drum HDPE 220L

Opaque container HDPE 640L

Opaque container HDPE 1000L

4.1.1.   Use-specific instructions for use

See general directions for use

4.1.2.   Use-specific risk mitigation measures

See general directions for use

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

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

5.1.   Instructions for use

Prior to the application of the product, clean with a detergent and rinse with drinking water.

Apply the product by circulation.

Product concentration: 0,4 %

Contact time:

| — | 5 minutes for bactericidal activity |
| --- | --- |

—

5 minutes for bactericidal activity

| — | 15 minutes for yeasticidal activity |
| --- | --- |

—

15 minutes for yeasticidal activity

Temperature of the product solution: 20 – 85 °C

Rinse with drinking water.

5.2.   Risk mitigation measures

| — | Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information). |
| --- | --- |

—

Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).

| — | Ensure adequate ventilation during the application. |
| --- | --- |

—

Ensure adequate ventilation during the application.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID

| — | IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.

| — | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.

| — | IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.

| — | IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.

See Safety Data Sheets. They contain an emergency phone number.

When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

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

Do not discharge the product directly to sewer or to the environment.

Dispose the product and its packaging in accordance with applicable local and national regulations.

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

Shelf-life: 2 years in HDPE

Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.

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) | DEPTACID CB |
| --- | --- |
| Authorisation number | EU-0021020-0003 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 10,0 |
| L-(+)-Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 17,6 |
| N,N-dimethyl-1-Decanamine, N-oxid | | Non-active substance | 2605-79-0 | 220-020-5 | 6,0 |

Trade name(s)

DEPTACID CB

Authorisation number

EU-0021020-0003 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

10,0

L-(+)-Lactic acid

Non-active substance

79-33-4

201-196-2

17,6

N,N-dimethyl-1-Decanamine, N-oxid

Non-active substance

2605-79-0

220-020-5

6,0

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

| Identifier | Meta SPC 4 |
| --- | --- |

Identifier

Meta SPC 4

1.2.   Suffix to the authorisation number

| Number | 1-4 |
| --- | --- |

Number

1-4

1.3.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (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 |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 3,0 | 3,0 |
| Methanesulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 21,0 | 21,0 |
| L-(+)-Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 0,0 | 0,0 |
| N,N-dimethyl-1-Decanamine, N-oxid | | Non-active substance | 2605-79-0 | 220-020-5 | 3,0 | 3,0 |
| Ethoxylated alcohol | Ethoxylated alcohol | Non-active substance | 31726-34-8 | 500-077-5 | 5,0 | 5,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Octanoic acid

Active Substance

124-07-2

204-677-5

3,0

3,0

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

21,0

21,0

L-(+)-Lactic acid

Non-active substance

79-33-4

201-196-2

0,0

0,0

N,N-dimethyl-1-Decanamine, N-oxid

Non-active substance

2605-79-0

220-020-5

3,0

3,0

Ethoxylated alcohol

Ethoxylated alcohol

Non-active substance

31726-34-8

500-077-5

5,0

5,0

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

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

| Hazard statements | May be corrosive to metals.
  Causes severe skin burns and eye damage.
  May cause respiratory irritation.
  Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  Wear face protection.
  IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
  IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER.
  Dispose of contents according to local/regional/national/international regulation.
  Avoid release to the environment. |

Hazard statements

May be corrosive to metals.

Causes severe skin burns and eye damage.

May cause respiratory irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER.

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

Avoid release to the environment.

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

4.1.   Use description

Table 5. Use # 1 – Separative membranes circulation

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  Disinfectant or cleaner-disinfectant for membranes used in reverse osmosis and nanofiltration in dairy and beverage industries. |
| Application method(s) | Closed system: Circulation |
| Application rate(s) and frequency | — | Use 0,75 % product solution if cleaning is applied prior to the disinfection |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Disinfectant or cleaner-disinfectant for membranes used in reverse osmosis and nanofiltration in dairy and beverage industries.

Application method(s)

Closed system: Circulation

Application rate(s) and frequency

—

Use 0,75 % product solution if cleaning is applied prior to the disinfection

| — | Use 1 % product solution if no cleaning is applied prior to the disinfection |
| --- | --- |

—

Use 1 % product solution if no cleaning is applied prior to the disinfection

1 to 3 cycles per day, 104 to 312 days per year

Category(ies) of users

Professional

Pack sizes and packaging material

Opaque jerrycan HDPE 5L

Opaque jerrycan HDPE 10L

Opaque jerrycan HDPE 22L

Opaque drum HDPE 60L

Opaque drum HDPE 120L

Opaque drum HDPE 220L

Opaque container HDPE 640L

Opaque container HDPE 1000L

4.1.1.   Use-specific instructions for use

See general directions for use

4.1.2.   Use-specific risk mitigation measures

See general directions for use

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

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

5.1.   Instructions for use

Rinse the membranes with drinking water or clean and rinse with drinking water before disinfection.

Apply the product by circulation

Product concentration if no cleaning is applied prior to the disinfection: 1 %

Product concentration if cleaning is applied prior to the disinfection: 0,75 %

Contact time:

| — | 5 minutes for bactericidal activity |
| --- | --- |

—

5 minutes for bactericidal activity

| — | 15 minutes for yeasticidal activity |
| --- | --- |

—

15 minutes for yeasticidal activity

Temperature of the product solution: 40 – 85 °C

Rinse with drinking water.

5.2.   Risk mitigation measures

| — | Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information). |
| --- | --- |

—

Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).

| — | Ensure adequate ventilation during the application. |
| --- | --- |

—

Ensure adequate ventilation during the application.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID

| — | IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.

| — | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.

| — | IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.

| — | IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician. |
| --- | --- |

—

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.

See Safety Data Sheets. They contain an emergency phone number

When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

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

Do not discharge the product directly to sewer or to the environment.

Dispose the product and its packaging in accordance with applicable local and national regulations.

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

Shelf life: 2 years in HDPE

Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.

6.   OTHER INFORMATION

The cleaning properties of the product has not been assessed as they are not covered by Regulation (EU) No 528/2012.

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) | DEPTACID WCM |
| --- | --- |
| Authorisation number | EU-0021020-0004 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 3,0 |
| Methanesulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 21,0 |
| N,N-dimethyl-1-Decanamine, N-oxid | | Non-active substance | 2605-79-0 | 220-020-5 | 3,0 |
| Ethoxylated alcohol | Ethoxylated alcohol | Non-active substance | 31726-34-8 | 500-077-5 | 5,0 |

Trade name(s)

DEPTACID WCM

Authorisation number

EU-0021020-0004 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

3,0

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

21,0

N,N-dimethyl-1-Decanamine, N-oxid

Non-active substance

2605-79-0

220-020-5

3,0

Ethoxylated alcohol

Ethoxylated alcohol

Non-active substance

31726-34-8

500-077-5

5,0

---

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.

---

| 28.4.2020 | EN | Official Journal of the European Union | L 133/23 |
| --- | --- | --- | --- |

28.4.2020

EN

Official Journal of the European Union

L 133/23

---

COMMISSION IMPLEMENTING REGULATION (EU) 2020/580

of 27 April 2020

granting a Union authorisation for the biocidal product family ‘SOPURCLEAN’

(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 the first subparagraph of Article 44(5) thereof,

Whereas:

| (1) | On 28 August 2015, SOPURA N.V., submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘SOPURCLEAN’ of product-type 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under the case number BC-PJ019489-22 in the Register for Biocidal Products. |
| --- | --- |

(1)

On 28 August 2015, SOPURA N.V., submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘SOPURCLEAN’ of product-type 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under the case number BC-PJ019489-22 in the Register for Biocidal Products.

| (2) | ‘SOPURCLEAN’ contains octanoic acid and decanoic acid, as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. |
| --- | --- |

(2)

‘SOPURCLEAN’ contains octanoic acid and decanoic acid, as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

| (3) | On 15 December 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). |
| --- | --- |

(3)

On 15 December 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

| (4) | On 15 July 2019, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘SOPURCLEAN’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 15 July 2019, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘SOPURCLEAN’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

| (5) | The opinion concludes that ‘SOPURCLEAN’ is a ‘biocidal product family’ within the meaning of 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, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
| --- | --- |

(5)

The opinion concludes that ‘SOPURCLEAN’ is a ‘biocidal product family’ within the meaning of 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, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

| (6) | On 26 July 2019, 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)

On 26 July 2019, 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.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘SOPURCLEAN’. |
| --- | --- |

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘SOPURCLEAN’.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(8)

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 with authorisation number EU-0021157-0000 is granted to SOPURA N.V. for the making available on the market and use of the biocidal product family ‘SOPURCLEAN’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 18 May 2020 until 30 April 2030.

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 April 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  ECHA opinion of 26 June 2019 on the Union authorisation of ‘SOPURCLEAN’ (ECHA/BPC/227/2019), https://echa.europa.eu/bpc-opinions-on-union-authorisation.

2

---

ANNEX

Summary of product characteristics for a biocidal product family

SOPURCLEAN

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0021157-0000

R4BP asset number: EU-0021157-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | SOPURCLEAN |
| --- | --- |

Name

SOPURCLEAN

1.2.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (Disinfectants)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | SOPURA N.V. |
| --- | --- | --- |
| Address | Rue de Trazegnies 199, 6180 COURCELLES, Belgium |
| Authorisation number | EU-0021157-0000 |
| R4BP asset number | EU-0021157-0000 |
| Date of the authorisation | 18 May 2020 |
| Expiry date of the authorisation | 30 April 2030 |

Name and address of the authorisation holder

Name

SOPURA N.V.

Address

Rue de Trazegnies 199, 6180 COURCELLES, Belgium

Authorisation number

EU-0021157-0000

R4BP asset number

EU-0021157-0000

Date of the authorisation

18 May 2020

Expiry date of the authorisation

30 April 2030

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | SOPURA N.V. |
| --- | --- |
| Address of manufacturer | Rue de Trazegnies 199, 6180 COURCELLES Belgium |
| Location of manufacturing sites | PIB de Tyberchamps 14, 7180 SENEFFE Belgium
  Rue de Trazegnies 199, 6180 COURCELLES Belgium |

Name of manufacturer

SOPURA N.V.

Address of manufacturer

Rue de Trazegnies 199, 6180 COURCELLES Belgium

Location of manufacturing sites

PIB de Tyberchamps 14, 7180 SENEFFE Belgium

Rue de Trazegnies 199, 6180 COURCELLES Belgium

| Name of manufacturer | SOPURA QUIMICA |
| --- | --- |
| Address of manufacturer | Poligon ‘La Canaleta’, Avinguda Júpiter 9, 25300 TARREGA Spain |
| Location of manufacturing sites | Poligon ‘La Canaleta’, Avinguda Júpiter 9, 25300 TARREGA Spain |

Name of manufacturer

SOPURA QUIMICA

Address of manufacturer

Poligon ‘La Canaleta’, Avinguda Júpiter 9, 25300 TARREGA Spain

Location of manufacturing sites

Poligon ‘La Canaleta’, Avinguda Júpiter 9, 25300 TARREGA Spain

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

| Active substance | Octanoic acid |
| --- | --- |
| Name of manufacturer | Emery Oleochemicals (M) Sdn Bhd (63112-D) |
| Address of manufacturer | Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia |
| Location of manufacturing sites | Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia |

Active substance

Octanoic acid

Name of manufacturer

Emery Oleochemicals (M) Sdn Bhd (63112-D)

Address of manufacturer

Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia

Location of manufacturing sites

Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia

| Active substance | Decanoic acid |
| --- | --- |
| Name of manufacturer | Emery Oleochemicals (M) Sdn Bhd (63112-D) |
| Address of manufacturer | Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia |
| Location of manufacturing sites | Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia |

Active substance

Decanoic acid

Name of manufacturer

Emery Oleochemicals (M) Sdn Bhd (63112-D)

Address of manufacturer

Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia

Location of manufacturing sites

Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia

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 |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,1 | 2,7 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 0,3 | 1,5 |
| Sulfuric acid | | Non-active substance | 7664-93-9 | 231-639-5 | 0,0 | 31,2 |
| Propionic acid | | Non-active substance | 79-09-4 | 201-176-3 | 0,0 | 19,5 |
| Phosphoric acid | | Non-active substance | 7664-38-2 | 231-633-2 | 0,0 | 30,0 |
| Nitric acid | | Non-active substance | 7697-37-2 | 231-714-2 | 0,0 | 18,0 |
| Methane sulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 0,0 | 20,3 |
| Glycolic acid | | Non-active substance | 79-14-1 | 201-180-5 | 0,0 | 4,2 |
| Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 0,0 | 35,2 |
| Citric acid | | Non-active substance | 77-92-9 | 201-069-1 | 0,0 | 3,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Octanoic acid

Active Substance

124-07-2

204-677-5

1,1

2,7

Decanoic acid

Active Substance

334-48-5

206-376-4

0,3

1,5

Sulfuric acid

Non-active substance

7664-93-9

231-639-5

0,0

31,2

Propionic acid

Non-active substance

79-09-4

201-176-3

0,0

19,5

Phosphoric acid

Non-active substance

7664-38-2

231-633-2

0,0

30,0

Nitric acid

Non-active substance

7697-37-2

231-714-2

0,0

18,0

Methane sulfonic acid

Non-active substance

75-75-2

200-898-6

0,0

20,3

Glycolic acid

Non-active substance

79-14-1

201-180-5

0,0

4,2

Lactic acid

Non-active substance

79-33-4

201-196-2

0,0

35,2

Citric acid

Non-active substance

77-92-9

201-069-1

0,0

3,0

2.2.   Type(s) of formulation

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

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 |
| --- | --- |

Identifier

Meta SPC 1

1.2.   Suffix to the authorisation number

| Number | 1-1 |
| --- | --- |

Number

1-1

1.3.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (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 |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,1 | 1,8 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 0,75 | 1,5 |
| Sulfuric acid | | Non-active substance | 7664-93-9 | 231-639-5 | 0,0 | 31,2 |
| Propionic acid | | Non-active substance | 79-09-4 | 201-176-3 | 0,0 | 0,0 |
| Phosphoric acid | | Non-active substance | 7664-38-2 | 231-633-2 | 0,0 | 30,0 |
| Nitric acid | | Non-active substance | 7697-37-2 | 231-714-2 | 0,0 | 0,0 |
| Methane sulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 0,0 | 12,6 |
| Glycolic acid | | Non-active substance | 79-14-1 | 201-180-5 | 0,0 | 4,2 |
| Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 0,0 | 0,0 |
| Citric acid | | Non-active substance | 77-92-9 | 201-069-1 | 0,0 | 3,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Octanoic acid

Active Substance

124-07-2

204-677-5

1,1

1,8

Decanoic acid

Active Substance

334-48-5

206-376-4

0,75

1,5

Sulfuric acid

Non-active substance

7664-93-9

231-639-5

0,0

31,2

Propionic acid

Non-active substance

79-09-4

201-176-3

0,0

0,0

Phosphoric acid

Non-active substance

7664-38-2

231-633-2

0,0

30,0

Nitric acid

Non-active substance

7697-37-2

231-714-2

0,0

0,0

Methane sulfonic acid

Non-active substance

75-75-2

200-898-6

0,0

12,6

Glycolic acid

Non-active substance

79-14-1

201-180-5

0,0

4,2

Lactic acid

Non-active substance

79-33-4

201-196-2

0,0

0,0

Citric acid

Non-active substance

77-92-9

201-069-1

0,0

3,0

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

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | May be corrosive to metals.
  Causes severe skin burns and eye damage. |
| --- | --- |
| Precautionary statements | Do not breathe vapours.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER.
  Immediately call a doctor.
  Wear eye protection.
  Wear face protection.
  Wear protective clothing.
  Wear protective gloves.
  IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
  IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water (or shower).
  Keep only in original container.
  Store in a well-ventilated place.Keep container tightly closed.
  Absorb spillage to prevent material damage.
  Dispose of contents in accordance with local/regional/national/international regulations. |

Hazard statements

May be corrosive to metals.

Causes severe skin burns and eye damage.

Precautionary statements

Do not breathe vapours.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER.

Immediately call a doctor.

Wear eye protection.

Wear face protection.

Wear protective clothing.

Wear protective gloves.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water (or shower).

Keep only in original container.

Store in a well-ventilated place.Keep container tightly closed.

Absorb spillage to prevent material damage.

Dispose of contents in accordance with local/regional/national/international regulations.

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

4.1.   Use description

Table 1

Use # 1 – Cleaning in place (CIP) with circulation

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  In food and feed areas |
| Application method(s) | Closed system
  For disinfection of pipes, tanks, and other parts of the closed system:






  — | Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements) |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

In food and feed areas

Application method(s)

Closed system

For disinfection of pipes, tanks, and other parts of the closed system:

—

Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)

| — | Circulation in a closed CIP system |
| --- | --- |

—

Circulation in a closed CIP system

Application rate(s) and frequency

| — | For an effect on bacteria and yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. |
| --- | --- |

—

For an effect on bacteria and yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

-

Category(ies) of users

Industrial

Trained professional

Pack sizes and packaging material

| • | Jerrycan High-density polyethylene (PE-HD), containing: 10 to 12,5 kg (*1). |
| --- | --- |

•

Jerrycan High-density polyethylene (PE-HD), containing: 10 to 12,5 kg (*1).

| • | Jerrycan (PE-HD), containing: 20 to 25 kg (*1). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 20 to 25 kg (*1).

| • | Drums (PE-HD) containing 200 to 250 kg (*1). |
| --- | --- |

•

Drums (PE-HD) containing 200 to 250 kg (*1).

| • | Containers (PE-HD) containing 600 to 750 kg (*1). |
| --- | --- |

•

Containers (PE-HD) containing 600 to 750 kg (*1).

| • | Intermediate bulk containers (IBC, PE-HD) containing 1 100 to 1 250 kg (*1) |
| --- | --- |

•

Intermediate bulk containers (IBC, PE-HD) containing 1 100 to 1 250 kg (*1)

| • | Bulk delivery. |
| --- | --- |

•

Bulk delivery.

4.1.1.   Use-specific instructions for use

In case of re-use of the disinfectant solution for CIP procedures, the active substance concentration must be measured and restored to its intended level before re-use.

4.1.2.   Use-specific risk mitigation measures

During the mixing, loading and application phases:

| — | Transfer in closed systems and industrial risk mitigation measures (RMM) excluding risk for skin and eye exposure (containers containing the product are connected to CIP via installed pipes; connections with dry coupling). |
| --- | --- |

—

Transfer in closed systems and industrial risk mitigation measures (RMM) excluding risk for skin and eye exposure (containers containing the product are connected to CIP via installed pipes; connections with dry coupling).

| — | Treated equipment (vessels) and dosing equipment has to be rinsed with drinking water after use. |
| --- | --- |

—

Treated equipment (vessels) and dosing equipment has to be rinsed with drinking water after use.

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 – Dipping/soaking

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  In food and feed areas |
| Application method(s) | Open system: immersion
  For disinfection of small hard non-porous parts (e.g. spare parts, tools, valves, hoses) used in the food manufacturing process:






  — | Concentrated product pumped in the bath and tap water added to reach the required concentration |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

In food and feed areas

Application method(s)

Open system: immersion

For disinfection of small hard non-porous parts (e.g. spare parts, tools, valves, hoses) used in the food manufacturing process:

—

Concentrated product pumped in the bath and tap water added to reach the required concentration

| — | Immersion |
| --- | --- |

—

Immersion

Application rate(s) and frequency

| — | For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to 20– 25 °C. |
| --- | --- |

—

For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to 20– 25 °C.

-

Category(ies) of users

Industrial

Trained professional

Pack sizes and packaging material

| • | Jerrycan (PE-HD), containing: 10 to 12,5 kg (*2). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 10 to 12,5 kg (*2).

| • | Jerrycan (PE-HD), containing: 20 to 25 kg (*2). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 20 to 25 kg (*2).

| • | Drums (PE-HD) containing 200 to 250 kg (*2). |
| --- | --- |

•

Drums (PE-HD) containing 200 to 250 kg (*2).

| • | Containers (PE-HD) containing 600 to 750 kg (*2). |
| --- | --- |

•

Containers (PE-HD) containing 600 to 750 kg (*2).

| • | IBC (PE-HD) containing 1 100 to 1 250 kg (*2) |
| --- | --- |

•

IBC (PE-HD) containing 1 100 to 1 250 kg (*2)

| • | Bulk delivery. |
| --- | --- |

•

Bulk delivery.

4.2.1.   Use-specific instructions for use

The dipping solution must be replaced by a fresh solution when it becomes visually polluted, and in all cases daily.

4.2.2.   Use-specific risk mitigation measures

During the post application phase:

Rinse the equipment with drinking water.

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

For an effect on bacteria and on yeasts

| • | Rinsing and cleaning before disinfection: |
| --- | --- |

•

Rinsing and cleaning before disinfection:

Not mandatory (even if a pre-rinsing is always recommended and usually performed by the users). For disinfection procedures in slaughterhouses, cleaning with a cold alkaline solution) is mandatory before disinfection.

| • | Disinfecting cycle:






  — | Dilution of the concentrated product in tap water before use: 1,5 % |
| --- | --- | --- |

•

Disinfecting cycle:

—

Dilution of the concentrated product in tap water before use: 1,5 %

In case of outbreaks of Pediococcus damnosus, the product must be used at 2 %.

| — | Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. |
| --- | --- |

—

Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

| • | Final rinsing with drinking water |
| --- | --- |

•

Final rinsing with drinking water

5.2.   Risk mitigation measures

Use in well-ventilated places.

During the mixing, loading and application phases: wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use eye protection during handling of the product. Wear face protection.

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

Particulars of likely direct or indirect adverse effects:

| • | Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns. |
| --- | --- |

•

Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns.

| • | If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis. |
| --- | --- |

•

If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis.

First aid instructions:

| • | Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles. |
| --- | --- |

•

Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

| • | In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures. |
| --- | --- |

•

In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures.

| • | In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. Keep a bottle of water at hand. |
| --- | --- |

•

In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. Keep a bottle of water at hand.

| • | In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing. |
| --- | --- |

•

In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing.

| • | In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital. |
| --- | --- |

•

In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital.

| • | NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent. |
| --- | --- |

•

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

| • | Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration. |
| --- | --- |

•

Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

| • | If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible. |
| --- | --- |

•

If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible.

| • | NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED! |
| --- | --- |

•

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

Advice for medical and healthcare personnel:

| • | In case of ingestion consider performing an endoscopic procedure. |
| --- | --- |

•

In case of ingestion consider performing an endoscopic procedure.

| • | The use of ipecac syrup, neutralization and activated charcoal is not advised. |
| --- | --- |

•

The use of ipecac syrup, neutralization and activated charcoal is not advised.

| • | Symptomatic and supportive treatment. |
| --- | --- |

•

Symptomatic and supportive treatment.

| • | WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER |
| --- | --- |

•

WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER

Emergency measures to protect the environment:

| • | Prevent entry into sewers and public waters. |
| --- | --- |

•

Prevent entry into sewers and public waters.

| • | Clean up any spills as soon as possible, using an absorbent material (e.g. earth, sand) to collect the spill. Use suitable disposal containers. |
| --- | --- |

•

Clean up any spills as soon as possible, using an absorbent material (e.g. earth, sand) to collect the spill. Use suitable disposal containers.

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place

Keep the product away from direct sunlight, source of heat and ignition.

The product must be stored at temperatures below +30 °C.

Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains.

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

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

Storage conditions:

| • | Store in a clean area allowing recuperation of leaks and effusion. |
| --- | --- |

•

Store in a clean area allowing recuperation of leaks and effusion.

| • | Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep container closed when not in use. |
| --- | --- |

•

Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep container closed when not in use.

| • | Handle in accordance with good industrial hygiene and safety procedures. |
| --- | --- |

•

Handle in accordance with good industrial hygiene and safety procedures.

Packaging material: Use approved materials suitable for corrosive liquids.

Shelf-life: 12 months in the original packaging.

6.   OTHER INFORMATION

Any product in meta SPC1 shall contain sufficient amounts of acids to yield a pH ≤ 2 at the dilution of 1,5 %.

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) | SEPTACID BN |
| --- | --- |
| Authorisation number | EU-0021157-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,5 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 1,5 |
| Sulfuric acid | | Non-active substance | 7664-93-9 | 231-639-5 | 31,2 |
| Glycolic acid | | Non-active substance | 79-14-1 | 201-180-5 | 4,2 |

Trade name(s)

SEPTACID BN

Authorisation number

EU-0021157-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

1,5

Decanoic acid

Active Substance

334-48-5

206-376-4

1,5

Sulfuric acid

Non-active substance

7664-93-9

231-639-5

31,2

Glycolic acid

Non-active substance

79-14-1

201-180-5

4,2

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

| Trade name(s) | SEPTACID BN PS |
| --- | --- |
| Authorisation number | EU-0021157-0002 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,5 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 1,5 |
| Phosphoric acid | | Non-active substance | 7664-38-2 | 231-633-2 | 30,0 |
| Glycolic acid | | Non-active substance | 79-14-1 | 201-180-5 | 4,2 |

Trade name(s)

SEPTACID BN PS

Authorisation number

EU-0021157-0002 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

1,5

Decanoic acid

Active Substance

334-48-5

206-376-4

1,5

Phosphoric acid

Non-active substance

7664-38-2

231-633-2

30,0

Glycolic acid

Non-active substance

79-14-1

201-180-5

4,2

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

| Trade name(s) | SOPURCIP EC |
| --- | --- |
| Authorisation number | EU-0021157-0003 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,1 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 0,75 |
| Sulfuric acid | | Non-active substance | 7664-93-9 | 231-639-5 | 7,8 |
| Methane sulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 12,6 |

Trade name(s)

SOPURCIP EC

Authorisation number

EU-0021157-0003 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

1,1

Decanoic acid

Active Substance

334-48-5

206-376-4

0,75

Sulfuric acid

Non-active substance

7664-93-9

231-639-5

7,8

Methane sulfonic acid

Non-active substance

75-75-2

200-898-6

12,6

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

| Trade name(s) | SOPURCLEAN BN |
| --- | --- |
| Authorisation number | EU-0021157-0004 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,8 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 1,2 |
| Sulfuric acid | | Non-active substance | 7664-93-9 | 231-639-5 | 29,64 |
| Citric acid | | Non-active substance | 77-92-9 | 201-069-1 | 3,0 |

Trade name(s)

SOPURCLEAN BN

Authorisation number

EU-0021157-0004 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

1,8

Decanoic acid

Active Substance

334-48-5

206-376-4

1,2

Sulfuric acid

Non-active substance

7664-93-9

231-639-5

29,64

Citric acid

Non-active substance

77-92-9

201-069-1

3,0

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

| Trade name(s) | SOPURCLEAN BN PS |
| --- | --- |
| Authorisation number | EU-0021157-0005 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,8 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 1,2 |
| Phosphoric acid | | Non-active substance | 7664-38-2 | 231-633-2 | 30,0 |
| Citric acid | | Non-active substance | 77-92-9 | 201-069-1 | 2,5 |

Trade name(s)

SOPURCLEAN BN PS

Authorisation number

EU-0021157-0005 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

1,8

Decanoic acid

Active Substance

334-48-5

206-376-4

1,2

Phosphoric acid

Non-active substance

7664-38-2

231-633-2

30,0

Citric acid

Non-active substance

77-92-9

201-069-1

2,5

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | Meta SPC 2 |
| --- | --- |

Identifier

Meta SPC 2

1.2.   Suffix to the authorisation number

| Number | 1-2 |
| --- | --- |

Number

1-2

1.3.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (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 |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 2,7 | 2,7 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 0,3 | 0,3 |
| Sulfuric acid | | Non-active substance | 7664-93-9 | 231-639-5 | 0,0 | 0,0 |
| Propionic acid | | Non-active substance | 79-09-4 | 201-176-3 | 19,5 | 19,5 |
| Phosphoric acid | | Non-active substance | 7664-38-2 | 231-633-2 | 3,8 | 3,8 |
| Nitric acid | | Non-active substance | 7697-37-2 | 231-714-2 | 0,0 | 0,0 |
| Methane sulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 0,0 | 0,0 |
| Glycolic acid | | Non-active substance | 79-14-1 | 201-180-5 | 0,0 | 0,0 |
| Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 35,2 | 35,2 |
| Citric acid | | Non-active substance | 77-92-9 | 201-069-1 | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Octanoic acid

Active Substance

124-07-2

204-677-5

2,7

2,7

Decanoic acid

Active Substance

334-48-5

206-376-4

0,3

0,3

Sulfuric acid

Non-active substance

7664-93-9

231-639-5

0,0

0,0

Propionic acid

Non-active substance

79-09-4

201-176-3

19,5

19,5

Phosphoric acid

Non-active substance

7664-38-2

231-633-2

3,8

3,8

Nitric acid

Non-active substance

7697-37-2

231-714-2

0,0

0,0

Methane sulfonic acid

Non-active substance

75-75-2

200-898-6

0,0

0,0

Glycolic acid

Non-active substance

79-14-1

201-180-5

0,0

0,0

Lactic acid

Non-active substance

79-33-4

201-196-2

35,2

35,2

Citric acid

Non-active substance

77-92-9

201-069-1

0,0

0,0

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

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | May be corrosive to metals.
  Causes severe skin burns and eye damage.
  May cause respiratory irritation. |
| --- | --- |
| Precautionary statements | Do not breathe vapours.
  Wear protective gloves.
  Wear protective clothing.
  Wear eye protection.
  Wear face protection.
  IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water (or shower).
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER.
  Immediately call a doctor.
  Keep only in original container.
  Store in a well-ventilated place.Keep container tightly closed.
  IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
  Dispose of contents in accordance with local/regional/national/international regulations. |

Hazard statements

May be corrosive to metals.

Causes severe skin burns and eye damage.

May cause respiratory irritation.

Precautionary statements

Do not breathe vapours.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

Wear face protection.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water (or shower).

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER.

Immediately call a doctor.

Keep only in original container.

Store in a well-ventilated place.Keep container tightly closed.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

Dispose of contents in accordance with local/regional/national/international regulations.

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

4.1.   Use description

Table 3

Use # 1 – Cleaning in place (CIP) with circulation

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  In food and feed areas |
| Application method(s) | Closed system
  For disinfection of pipes, tanks, and other parts of the closed system:






  — | Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements) |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

In food and feed areas

Application method(s)

Closed system

For disinfection of pipes, tanks, and other parts of the closed system:

—

Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)

| — | Circulation in a closed CIP system |
| --- | --- |

—

Circulation in a closed CIP system

Application rate(s) and frequency

- - For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v In case of outbreaks of Pediococcus damnosus, the product must be used at 1,5 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

-

Category(ies) of users

Industrial

Trained professional

Pack sizes and packaging material

| • | Jerrycan (PE-HD), containing: 10 to 12,5 kg (*3). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 10 to 12,5 kg (*3).

| • | Jerrycan (PE-HD), containing: 20 to 25 kg (*3). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 20 to 25 kg (*3).

| • | Drums (PE-HD) containing 200 to 250 kg (*3).






  • | Containers (PE-HD) containing 600 to 750 kg (*3) |
| --- | --- | --- |

•

Drums (PE-HD) containing 200 to 250 kg (*3).

•

Containers (PE-HD) containing 600 to 750 kg (*3)

| • | IBC (PE-HD) containing 1 100 to 1 250 kg (*3) |
| --- | --- |

•

IBC (PE-HD) containing 1 100 to 1 250 kg (*3)

| • | Bulk delivery. |
| --- | --- |

•

Bulk delivery.

4.1.1.   Use-specific instructions for use

In case of re-use of the disinfectant solution for CIP procedures, the active substance concentration must be measured and restored to its intended level before re-use.

4.1.2.   Use-specific risk mitigation measures

During the mixing, loading and application phases:

| — | Transfer in closed systems and industrial RMM excluding risk for skin and eye exposure.IBC containers containing the product are connected to CIP via installed pipes; connections are made with dry coupling. |
| --- | --- |

—

Transfer in closed systems and industrial RMM excluding risk for skin and eye exposure.IBC containers containing the product are connected to CIP via installed pipes; connections are made with dry coupling.

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 – Spraying

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  In food and feed areas |
| Application method(s) | Spraying
  For disinfection of hard non-porous surfaces in contact with food processing:






  — | Diluted biocidal product sprayed via a low pressure spraying device |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

In food and feed areas

Application method(s)

Spraying

For disinfection of hard non-porous surfaces in contact with food processing:

—

Diluted biocidal product sprayed via a low pressure spraying device

Application rate(s) and frequency

Maximum application rate: 100 mL/m2 – For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the product must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

-

Category(ies) of users

Industrial

Trained professional

Pack sizes and packaging material

Jerrycan (PE-HD), containing: 10 to 12,5 kg (*4).

| • | Jerrycan (PE-HD), containing: 20 to 25 kg (*4). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 20 to 25 kg (*4).

| • | Drums (PE-HD) containing 200 to 250 kg (*4).






  • | Containers (PE-HD) containing 600 to 750 kg. (*4) |
| --- | --- | --- |

•

Drums (PE-HD) containing 200 to 250 kg (*4).

•

Containers (PE-HD) containing 600 to 750 kg. (*4)

| • | IBC (PE-HD) containing 1 100 to 1 250 kg (*4) |
| --- | --- |

•

IBC (PE-HD) containing 1 100 to 1 250 kg (*4)

| • | Bulk delivery. |
| --- | --- |

•

Bulk delivery.

4.2.1.   Use-specific instructions for use

See general directions for use.

4.2.2.   Use-specific risk mitigation measures

Fully automated process where workers are not present during spraying.

Workers only re-enter in the work area when spraying solution has been drained.

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 5

Use # 3 – Manual disinfection

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeast |
| Field(s) of use | Indoor
  In food and feed areas |
| Application method(s) | Manual application
  For disinfection of hard non-porous small parts and surfaces used in the food manufacturing process:






  — | Diluted product sprayed via a low pressure spraying device |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeast

Field(s) of use

Indoor

In food and feed areas

Application method(s)

Manual application

For disinfection of hard non-porous small parts and surfaces used in the food manufacturing process:

—

Diluted product sprayed via a low pressure spraying device

| — | After the optimal contact time for disinfection, the small parts are to be wiped or mopped or brushed. |
| --- | --- |

—

After the optimal contact time for disinfection, the small parts are to be wiped or mopped or brushed.

Application rate(s) and frequency

Maximum application rate: 100 mL/m2 – For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

-

Category(ies) of users

Industrial

Trained professional

Pack sizes and packaging material

Jerrycan (PE-HD), containing: 10 to 12,5 kg (*5).

| • | Jerrycan (PE-HD), containing: 20 to 25 kg (*5). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 20 to 25 kg (*5).

| • | Drums (PE-HD) containing 200 to 250 kg (*5).






  • | Containers (PE-HD) containing 600 to 750 kg (*5). |
| --- | --- | --- |

•

Drums (PE-HD) containing 200 to 250 kg (*5).

•

Containers (PE-HD) containing 600 to 750 kg (*5).

| • | IBC (PE-HD) containing 1 100 to 1 250 kg (*5) |
| --- | --- |

•

IBC (PE-HD) containing 1 100 to 1 250 kg (*5)

| • | Bulk delivery. |
| --- | --- |

•

Bulk delivery.

4.3.1.   Use-specific instructions for use

See general directions for use.

4.3.2.   Use-specific risk mitigation measures

See general directions for use.

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 6

Use # 4 – Dipping/soaking

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  In food and feed areas |
| Application method(s) | Open system: immersion
  For disinfection of hard non-porous small parts (e.g. spare parts, tools, valves, hoses) used in the food manufacturing process:






  — | Concentrated product pumped in the bath and tap water added to reach the required concentration |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

In food and feed areas

Application method(s)

Open system: immersion

For disinfection of hard non-porous small parts (e.g. spare parts, tools, valves, hoses) used in the food manufacturing process:

—

Concentrated product pumped in the bath and tap water added to reach the required concentration

| — | Immersion |
| --- | --- |

—

Immersion

Application rate(s) and frequency

| — | For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. |
| --- | --- |

—

For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

-

Category(ies) of users

Industrial

Trained professional

Pack sizes and packaging material

Jerrycan (PE-HD), containing: 10 to 12,5 kg (*6).

Jerrycan (PE-HD), containing: 20 to 25 kg (*6).

Drums (PE-HD) containing 200 to 250 kg (*6).

Containers (PE-HD) containing 600 to 750 kg (*6).

IBC (Internal bulk containers, PE-HD) containing 1 100 to 1 250 kg (*6)

Bulk delivery.

4.4.1.   Use-specific instructions for use

The dipping solution must be replaced by a fresh solution when it becomes visually polluted, and in all cases daily.

4.4.2.   Use-specific risk mitigation measures

See general directions for use.

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 (2)
  OF THE META SPC 2

5.1.   Instructions for use

For an effect on bacteria and on yeasts

| • | Rinsing and cleaning before disinfection: Not mandatory (even if a pre-rinsing is always recommended and usually performed by the users). |
| --- | --- |

•

Rinsing and cleaning before disinfection: Not mandatory (even if a pre-rinsing is always recommended and usually performed by the users).

For disinfection procedures in slaughterhouses, cleaning with a cold alkaline solutionis mandatory before disinfection.

| • | Disinfecting cycle:






  — | Dilution of the concentrated product in tap water before use: 1,0 %. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %. |
| --- | --- | --- |

•

Disinfecting cycle:

—

Dilution of the concentrated product in tap water before use: 1,0 %. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %.

| — | Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. |
| --- | --- |

—

Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

| — | Disinfection via spraying/manual disinfection: Make sure to wet surfaces completely. |
| --- | --- |

—

Disinfection via spraying/manual disinfection: Make sure to wet surfaces completely.

| • | Final rinsing: not necessary |
| --- | --- |

•

Final rinsing: not necessary

5.2.   Risk mitigation measures

During the mixing and loading and application phases: wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use of eye protection during handling of the product. Wear face protection.

Use in well ventilated places.

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

Particulars of likely direct or indirect adverse effects:

| • | Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns. |
| --- | --- |

•

Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns.

| • | If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis. |
| --- | --- |

•

If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis.

First aid instructions:

| • | Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles. |
| --- | --- |

•

Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

| • | In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures. |
| --- | --- |

•

In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures.

| • | In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. Keep a bottle of water at hand. |
| --- | --- |

•

In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. Keep a bottle of water at hand.

| • | In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing. |
| --- | --- |

•

In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing.

| • | In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital. |
| --- | --- |

•

In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital.

| • | NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent. |
| --- | --- |

•

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

| • | Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration. |
| --- | --- |

•

Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

| • | If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible. |
| --- | --- |

•

If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible.

| • | NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED! |
| --- | --- |

•

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

Advice for medical and healthcare personnel:

| • | In case of ingestion consider performing an endoscopic procedure. |
| --- | --- |

•

In case of ingestion consider performing an endoscopic procedure.

| • | The use of ipecac syrup, neutralization and activated charcoal is not advised. |
| --- | --- |

•

The use of ipecac syrup, neutralization and activated charcoal is not advised.

| • | Symptomatic and supportive treatment. |
| --- | --- |

•

Symptomatic and supportive treatment.

| • | WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER |
| --- | --- |

•

WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER

Emergency measures to protect the environment:

| • | Prevent entry into sewers and public waters. |
| --- | --- |

•

Prevent entry into sewers and public waters.

| • | Clean up any spills as soon as possible, using an absorbent material (earth, sand, ...) to collect the spill. Use suitable disposal containers. |
| --- | --- |

•

Clean up any spills as soon as possible, using an absorbent material (earth, sand, ...) to collect the spill. Use suitable disposal containers.

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place

Keep the product away from direct sunlight, source of heat and ignition.

The product must be stored at temperatures below +30 °C.

Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

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

Storage conditions:

| • | Store in a clean area allowing recuperation of leaks and effusion. |
| --- | --- |

•

Store in a clean area allowing recuperation of leaks and effusion.

| • | Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep packaging closed when not in use. |
| --- | --- |

•

Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep packaging closed when not in use.

| • | Handle in accordance with good industrial hygiene and safety procedures. |
| --- | --- |

•

Handle in accordance with good industrial hygiene and safety procedures.

Packaging material: Use approved materials suitable for corrosive liquids.

Shelf-life: 12 months in the original packaging.

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) | SOPURCLEAN NR |
| --- | --- |
| Authorisation number | EU-0021157-0006 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 2,7 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 0,3 |
| Propionic acid | | Non-active substance | 79-09-4 | 201-176-3 | 19,5 |
| Phosphoric acid | | Non-active substance | 7664-38-2 | 231-633-2 | 3,8 |
| Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 35,2 |

Trade name(s)

SOPURCLEAN NR

Authorisation number

EU-0021157-0006 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

2,7

Decanoic acid

Active Substance

334-48-5

206-376-4

0,3

Propionic acid

Non-active substance

79-09-4

201-176-3

19,5

Phosphoric acid

Non-active substance

7664-38-2

231-633-2

3,8

Lactic acid

Non-active substance

79-33-4

201-196-2

35,2

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

| Identifier | Meta SPC 3 |
| --- | --- |

Identifier

Meta SPC 3

1.2.   Suffix to the authorisation number

| Number | 1-3 |
| --- | --- |

Number

1-3

1.3.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (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 |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,8 | 1,8 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 1,2 | 1,2 |
| Sulfuric acid | | Non-active substance | 7664-93-9 | 231-639-5 | 0,0 | 0,0 |
| Propionic acid | | Non-active substance | 79-09-4 | 201-176-3 | 0,0 | 0,0 |
| Phosphoric acid | | Non-active substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Nitric acid | | Non-active substance | 7697-37-2 | 231-714-2 | 18,0 | 18,0 |
| Methane sulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 0,0 | 0,0 |
| Glycolic acid | | Non-active substance | 79-14-1 | 201-180-5 | 0,0 | 0,0 |
| Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 0,0 | 0,0 |
| Citric acid | | Non-active substance | 77-92-9 | 201-069-1 | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Octanoic acid

Active Substance

124-07-2

204-677-5

1,8

1,8

Decanoic acid

Active Substance

334-48-5

206-376-4

1,2

1,2

Sulfuric acid

Non-active substance

7664-93-9

231-639-5

0,0

0,0

Propionic acid

Non-active substance

79-09-4

201-176-3

0,0

0,0

Phosphoric acid

Non-active substance

7664-38-2

231-633-2

0,0

0,0

Nitric acid

Non-active substance

7697-37-2

231-714-2

18,0

18,0

Methane sulfonic acid

Non-active substance

75-75-2

200-898-6

0,0

0,0

Glycolic acid

Non-active substance

79-14-1

201-180-5

0,0

0,0

Lactic acid

Non-active substance

79-33-4

201-196-2

0,0

0,0

Citric acid

Non-active substance

77-92-9

201-069-1

0,0

0,0

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

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

| Hazard statements | May be corrosive to metals.
  Causes severe skin burns and eye damage.
  Harmful if inhaled. |
| --- | --- |
| Precautionary statements | Do not breathe vapours.
  Wear protective clothing.
  Wear eye protection.
  Wear protective gloves.
  Wear face protection.
  IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a doctor.
  Immediately call a POISON CENTER.
  Keep only in original container.
  IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
  Store in a well-ventilated place.Keep container tightly closed.
  Absorb spillage to prevent material damage.
  Dispose of contents in accordance with local/regional/national/international regulations. |

Hazard statements

May be corrosive to metals.

Causes severe skin burns and eye damage.

Harmful if inhaled.

Precautionary statements

Do not breathe vapours.

Wear protective clothing.

Wear eye protection.

Wear protective gloves.

Wear face protection.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a doctor.

Immediately call a POISON CENTER.

Keep only in original container.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

Store in a well-ventilated place.Keep container tightly closed.

Absorb spillage to prevent material damage.

Dispose of contents in accordance with local/regional/national/international regulations.

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

4.1.   Use description

Table 7

Use # 1 – Cleaning in place (CIP) with circulation

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  In food and feed areas |
| Application method(s) | Closed system
  For disinfection of pipes, tanks, and other parts of the closed system.






  — | Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements) |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

In food and feed areas

Application method(s)

Closed system

For disinfection of pipes, tanks, and other parts of the closed system.

—

Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)

| — | Circulation in a closed CIP system |
| --- | --- |

—

Circulation in a closed CIP system

Application rate(s) and frequency

| — | For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. |
| --- | --- |

—

For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

-

Category(ies) of users

Industrial

Trained professional

Pack sizes and packaging material

| • | Jerrycan (PE-HD), containing: 10 to 12,5 kg (*7). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 10 to 12,5 kg (*7).

| • | Jerrycan (PE-HD), containing: 20 to 25 kg (*7). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 20 to 25 kg (*7).

| • | Drums (PE-HD) containing 200 to 250 kg (*7). |
| --- | --- |

•

Drums (PE-HD) containing 200 to 250 kg (*7).

| • | Containers (PE-HD) containing 600 to 750 kg (*7). |
| --- | --- |

•

Containers (PE-HD) containing 600 to 750 kg (*7).

| • | IBC (PE-HD) containing 1 100 to 1 250 kg (*7) |
| --- | --- |

•

IBC (PE-HD) containing 1 100 to 1 250 kg (*7)

| • | Bulk delivery. |
| --- | --- |

•

Bulk delivery.

4.1.1.   Use-specific instructions for use

In case of re-use of the disinfectant solution for CIP procedures, the active substance concentration must be measured and restored to its intended level before re-use.

4.1.2.   Use-specific risk mitigation measures

During the mixing, loading and application phases:

| — | Transfer in closed systems and industrial RMM excluding risk for skin and eye exposure. (Containers containing the product are connected to CIP via installed pipes; connections are made with dry coupling. |
| --- | --- |

—

Transfer in closed systems and industrial RMM excluding risk for skin and eye exposure. (Containers containing the product are connected to CIP via installed pipes; connections are made with dry coupling.

During the mixing and loading phases:

| — | Wear respiratory mask. |
| --- | --- |

—

Wear respiratory mask.

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.

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

5.1.   Instructions for use

For an effect on bacteria and on yeasts

| • | Rinsing and cleaning before disinfection: |
| --- | --- |

•

Rinsing and cleaning before disinfection:

Not mandatory (even if a pre-rinsing is always recommended and usually performed by the users).

For disinfection procedures in slaughterhouses, cleaning with a cold alkaline solution is mandatory before disinfection.

| • | Disinfecting cycle:






  — | Dilution of the concentrated product in tap water before use: 1,5 % |
| --- | --- | --- |

•

Disinfecting cycle:

—

Dilution of the concentrated product in tap water before use: 1,5 %

In case of outbreaks of Pediococcus damnosus, the product must be used at 2 %.

| — | Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. |
| --- | --- |

—

Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

| • | Final rinsing with drinking water |
| --- | --- |

•

Final rinsing with drinking water

5.2.   Risk mitigation measures

Use in well-ventilated places.

During the mixing, loading and application phases:

Wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use of eye protection during handling of the product. Wear face protection.

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

Particulars of likely direct or indirect adverse effects:

| • | Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns. |
| --- | --- |

•

Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns.

| • | If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis. |
| --- | --- |

•

If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis.

First aid instructions:

| • | Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles. |
| --- | --- |

•

Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

| • | In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures. |
| --- | --- |

•

In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures.

| • | In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. (Keep a bottle of water at hand). |
| --- | --- |

•

In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. (Keep a bottle of water at hand).

| • | In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing. |
| --- | --- |

•

In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing.

| • | In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital. |
| --- | --- |

•

In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital.

| • | NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent. |
| --- | --- |

•

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

| • | Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration. |
| --- | --- |

•

Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

| • | If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible. |
| --- | --- |

•

If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible.

| • | NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED! |
| --- | --- |

•

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

Advice for medical and healthcare personnel:

| • | In case of ingestion consider performing an endoscopic procedure. |
| --- | --- |

•

In case of ingestion consider performing an endoscopic procedure.

| • | The use of ipecac syrup, neutralization and activated charcoal is not advised. |
| --- | --- |

•

The use of ipecac syrup, neutralization and activated charcoal is not advised.

| • | Symptomatic and supportive treatment. |
| --- | --- |

•

Symptomatic and supportive treatment.

| • | WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER |
| --- | --- |

•

WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER

Emergency measures to protect the environment:

| • | Prevent entry into sewers and public waters. |
| --- | --- |

•

Prevent entry into sewers and public waters.

| • | Clean up any spills as soon as possible, using an absorbent material (e.g. earth, sand) to collect the spill. Use suitable disposal containers. |
| --- | --- |

•

Clean up any spills as soon as possible, using an absorbent material (e.g. earth, sand) to collect the spill. Use suitable disposal containers.

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place

Keep the product away from direct sunlight, source of heat and ignition.

The product must be stored at temperatures below +30 °C.

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

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

Storage conditions:

| • | Store in a clean area allowing recuperation of leaks and effusion. |
| --- | --- |

•

Store in a clean area allowing recuperation of leaks and effusion.

| • | Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep packaging closed when not in use. |
| --- | --- |

•

Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep packaging closed when not in use.

| • | Handle in accordance with good industrial hygiene and safety procedures. |
| --- | --- |

•

Handle in accordance with good industrial hygiene and safety procedures.

Packaging material: Use approved materials suitable for corrosive liquids.

Shelf-life: 12 months in the original packaging.

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) | SOPURCLEAN OP-N |
| --- | --- |
| Authorisation number | EU-0021157-0007 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,8 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 1,2 |
| Nitric acid | | Non-active substance | 7697-37-2 | 231-714-2 | 18,0 |

Trade name(s)

SOPURCLEAN OP-N

Authorisation number

EU-0021157-0007 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

1,8

Decanoic acid

Active Substance

334-48-5

206-376-4

1,2

Nitric acid

Non-active substance

7697-37-2

231-714-2

18,0

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

| Identifier | Meta SPC 4 |
| --- | --- |

Identifier

Meta SPC 4

1.2.   Suffix to the authorisation number

| Number | 1-4 |
| --- | --- |

Number

1-4

1.3.   Product type(s)

| Product type(s) | PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT04 – Food and feed area (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 |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,8 | 1,8 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 1,2 | 1,2 |
| Sulfuric acid | | Non-active substance | 7664-93-9 | 231-639-5 | 4,68 | 4,68 |
| Propionic acid | | Non-active substance | 79-09-4 | 201-176-3 | 0,0 | 0,0 |
| Phosphoric acid | | Non-active substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Nitric acid | | Non-active substance | 7697-37-2 | 231-714-2 | 0,0 | 0,0 |
| Methane sulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 20,3 | 20,3 |
| Glycolic acid | | Non-active substance | 79-14-1 | 201-180-5 | 0,0 | 0,0 |
| Lactic acid | | Non-active substance | 79-33-4 | 201-196-2 | 0,0 | 0,0 |
| Citric acid | | Non-active substance | 77-92-9 | 201-069-1 | 0,0 | 0,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Octanoic acid

Active Substance

124-07-2

204-677-5

1,8

1,8

Decanoic acid

Active Substance

334-48-5

206-376-4

1,2

1,2

Sulfuric acid

Non-active substance

7664-93-9

231-639-5

4,68

4,68

Propionic acid

Non-active substance

79-09-4

201-176-3

0,0

0,0

Phosphoric acid

Non-active substance

7664-38-2

231-633-2

0,0

0,0

Nitric acid

Non-active substance

7697-37-2

231-714-2

0,0

0,0

Methane sulfonic acid

Non-active substance

75-75-2

200-898-6

20,3

20,3

Glycolic acid

Non-active substance

79-14-1

201-180-5

0,0

0,0

Lactic acid

Non-active substance

79-33-4

201-196-2

0,0

0,0

Citric acid

Non-active substance

77-92-9

201-069-1

0,0

0,0

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

| Formulation(s) | SL – Soluble concentrate |
| --- | --- |

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

| Hazard statements | May be corrosive to metals.
  Causes severe skin burns and eye damage.
  May cause respiratory irritation. |
| --- | --- |
| Precautionary statements | Do not breathe vapours.
  Wear protective clothing.
  Wear eye protection.
  Wear protective gloves.
  Wear face protection.
  IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER.
  Immediately call a doctor.
  IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
  Keep only in original container.
  Store in a well-ventilated place.Keep container tightly closed.
  Absorb spillage to prevent material damage.
  Dispose of contents in accordance with local/regional/national/international regulations. |

Hazard statements

May be corrosive to metals.

Causes severe skin burns and eye damage.

May cause respiratory irritation.

Precautionary statements

Do not breathe vapours.

Wear protective clothing.

Wear eye protection.

Wear protective gloves.

Wear face protection.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER.

Immediately call a doctor.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

Keep only in original container.

Store in a well-ventilated place.Keep container tightly closed.

Absorb spillage to prevent material damage.

Dispose of contents in accordance with local/regional/national/international regulations.

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

4.1.   Use description

Table 8

Use # 1 – Cleaning in place (CIP) with circulation

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Bacteria
  Yeasts |
| Field(s) of use | Indoor
  In food and feed areas |
| Application method(s) | Closed system
  For disinfection of pipes, tanks, and other parts of the closed system.






  — | Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements) |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

In food and feed areas

Application method(s)

Closed system

For disinfection of pipes, tanks, and other parts of the closed system.

—

Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)

| — | Circulation in a closed CIP system |
| --- | --- |

—

Circulation in a closed CIP system

Application rate(s) and frequency

| — | For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. |
| --- | --- |

—

For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

Category(ies) of users

Industrial

Trained professional

Pack sizes and packaging material

| • | Jerrycan (PE-HD), containing: 10 to 12,5 kg (*8). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 10 to 12,5 kg (*8).

| • | Jerrycan (PE-HD), containing: 20 to 25 kg (*8). |
| --- | --- |

•

Jerrycan (PE-HD), containing: 20 to 25 kg (*8).

| • | Drums (PE-HD) containing 200 to 250 kg (*8). |
| --- | --- |

•

Drums (PE-HD) containing 200 to 250 kg (*8).

| • | Containers (PE-HD) containing 600 to 750 kg (*8). |
| --- | --- |

•

Containers (PE-HD) containing 600 to 750 kg (*8).

| • | IBC (PE-HD) containing 1 100 to 1 250 kg (*8) |
| --- | --- |

•

IBC (PE-HD) containing 1 100 to 1 250 kg (*8)

| • | Bulk delivery. |
| --- | --- |

•

Bulk delivery.

4.1.1.   Use-specific instructions for use

In case of re-use of the disinfectant solution for CIP procedures, the active substance concentration must be measured and restored to its intended level before re-use.

4.1.2.   Use-specific risk mitigation measures

During the mixing, loading and application phase:

| — | Transfer in closed systems and industrial RMM excluding risk for skin and eye exposure, IBC containers containing the product are connected to CIP via installed pipes; connections are made with dry coupling. |
| --- | --- |

—

Transfer in closed systems and industrial RMM excluding risk for skin and eye exposure, IBC containers containing the product are connected to CIP via installed pipes; connections are made with dry coupling.

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.

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

5.1.   Instructions for use

For an effect on bacteria and on yeasts

| • | Rinsing and cleaning before disinfection: |
| --- | --- |

•

Rinsing and cleaning before disinfection:

Not mandatory (even if a pre-rinsing is always recommended and usually performed by the users).

For disinfection procedures in slaughterhouses, cleaning with a cold alkaline solution is mandatory before disinfection.

| • | Disinfecting cycle:






  — | Dilution of the concentrated product in tap water before use:1,5 % |
| --- | --- | --- |

•

Disinfecting cycle:

—

Dilution of the concentrated product in tap water before use:1,5 %

In case of outbreaks of Pediococcus damnosus, the products must be used at 2 %.

| — | Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C. |
| --- | --- |

—

Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

| • | Final rinsing with drinking water |
| --- | --- |

•

Final rinsing with drinking water

5.2.   Risk mitigation measures

Use in well-ventilated places.

During the mixing, loading and application phases:

Wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use eye protection during handling of the product. Wear face protection.

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

Particulars of likely direct or indirect adverse effects:

| • | Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns. |
| --- | --- |

•

Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns.

| • | If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis. |
| --- | --- |

•

If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis.

First aid instructions:

| • | Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles. |
| --- | --- |

•

Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

| • | In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures. |
| --- | --- |

•

In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures.

| • | In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. (Keep a bottle of water at hand). |
| --- | --- |

•

In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. (Keep a bottle of water at hand).

| • | In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing. |
| --- | --- |

•

In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing.

| • | In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital. |
| --- | --- |

•

In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital.

| • | NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent. |
| --- | --- |

•

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

| • | Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration. |
| --- | --- |

•

Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

| • | If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible. |
| --- | --- |

•

If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible.

| • | NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED! |
| --- | --- |

•

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

Advice for medical and healthcare personnel:

| • | In case of ingestion consider performing an endoscopic procedure. |
| --- | --- |

•

In case of ingestion consider performing an endoscopic procedure.

| • | The use of ipecac syrup, neutralization and activated charcoal is not advised. |
| --- | --- |

•

The use of ipecac syrup, neutralization and activated charcoal is not advised.

| • | Symptomatic and supportive treatment. |
| --- | --- |

•

Symptomatic and supportive treatment.

| • | WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER |
| --- | --- |

•

WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER

Emergency measures to protect the environment:

| • | Prevent entry into sewers and public waters. |
| --- | --- |

•

Prevent entry into sewers and public waters.

| • | Clean up any spills as soon as possible, using an absorbent material (e.g. earth, sand) to collect the spill. Use suitable disposal containers. |
| --- | --- |

•

Clean up any spills as soon as possible, using an absorbent material (e.g. earth, sand) to collect the spill. Use suitable disposal containers.

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place

Keep the product away from direct sunlight, source of heat and ignition.

The product must be stored at temperatures below +30 °C.

Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

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

Storage conditions:

| • | Store in a clean area allowing recuperation of leaks and effusion. |
| --- | --- |

•

Store in a clean area allowing recuperation of leaks and effusion.

| • | Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep packaging closed when not in use. |
| --- | --- |

•

Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep packaging closed when not in use.

| • | Handle in accordance with good industrial hygiene and safety procedures. |
| --- | --- |

•

Handle in accordance with good industrial hygiene and safety procedures.

Packaging material: Use approved materials suitable for corrosive liquids.

Shelf-life: 12 months in the original packaging.

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) | SOPURCLEAN CIP OP |
| --- | --- |
| Authorisation number | EU-0021157-0008 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Octanoic acid | | Active Substance | 124-07-2 | 204-677-5 | 1,8 |
| Decanoic acid | | Active Substance | 334-48-5 | 206-376-4 | 1,2 |
| Sulfuric acid | | Non-active substance | 7664-93-9 | 231-639-5 | 4,68 |
| Methane sulfonic acid | | Non-active substance | 75-75-2 | 200-898-6 | 20,3 |

Trade name(s)

SOPURCLEAN CIP OP

Authorisation number

EU-0021157-0008 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Octanoic acid

Active Substance

124-07-2

204-677-5

1,8

Decanoic acid

Active Substance

334-48-5

206-376-4

1,2

Sulfuric acid

Non-active substance

7664-93-9

231-639-5

4,68

Methane sulfonic acid

Non-active substance

75-75-2

200-898-6

20,3

---

(*1)  Depending on biocidal product specific weight.

(*2)  Depending on biocidal product specific weight.

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(*3)  Depending on biocidal product specific weight.

(*4)  Depending on biocidal product specific weight.

(*5)  Depending on biocidal product specific weight.

(*6)  Depending on biocidal product specific weight.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(*7)  Depending on biocidal product specific weight.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

(*8)  Depending on biocidal product specific weight.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.

---

| 28.4.2020 | EN | Official Journal of the European Union | L 133/52 |
| --- | --- | --- | --- |

28.4.2020

EN

Official Journal of the European Union

L 133/52

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/581

of 27 April 2020

amending Implementing Regulation (EU) 2018/659 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (1), and in particular Article 17(3) thereof,

Having regard to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae (2), and in particular Article 12(1) and (4), Article 13(2), Article 16 and Article 19(b) thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) 2018/659 (3) lays down the conditions for entry into the Union of equidae and of semen, ova and embryos of equidae. It sets out the list of third countries from where Member States are to authorise the entry of equidae and of semen, ova and embryos of animals of the equine species, and specifies the animal health and veterinary certification conditions for such entries. |
| --- | --- |

(1)

Commission Implementing Regulation (EU) 2018/659 (3) lays down the conditions for entry into the Union of equidae and of semen, ova and embryos of equidae. It sets out the list of third countries from where Member States are to authorise the entry of equidae and of semen, ova and embryos of animals of the equine species, and specifies the animal health and veterinary certification conditions for such entries.

| (2) | Directive 2009/156/EC lays down the animal health requirements governing imports of equidae into the Union. It provides that imports of equidae into the Union are only authorised from third countries or parts of the territory thereof which have been free from glanders (Burgholderia mallei) for a period of at least six months. |
| --- | --- |

(2)

Directive 2009/156/EC lays down the animal health requirements governing imports of equidae into the Union. It provides that imports of equidae into the Union are only authorised from third countries or parts of the territory thereof which have been free from glanders (Burgholderia mallei) for a period of at least six months.

| (3) | On 25 December 2019, Turkey notified through the Animal Disease Notification System, that a case of glanders was confirmed on 4 December 2019 in a horse on the Büyükada Island, Province of Istanbul, Turkey. The entry into the Union of equidae and of germinal products of equidae from Turkey should be suspended for a period of at least 6 months. It is therefore necessary to amend the entry for Turkey in Annex I to Implementing Regulation (EU) 2018/659. |
| --- | --- |

(3)

On 25 December 2019, Turkey notified through the Animal Disease Notification System, that a case of glanders was confirmed on 4 December 2019 in a horse on the Büyükada Island, Province of Istanbul, Turkey. The entry into the Union of equidae and of germinal products of equidae from Turkey should be suspended for a period of at least 6 months. It is therefore necessary to amend the entry for Turkey in Annex I to Implementing Regulation (EU) 2018/659.

| (4) | A new Show Jumping League has been established in the United Arab Emirates under the auspices of the Fédération Equestre Internationale (‘FEI’) which includes qualifying tests for the Show Jumping World Cup. Based on the animal health guarantees provided by the United Arab Emirates, adding the series of show jumping competitions of the United Arab Emirates International Show Jumping League to the list of events for which the re-entry into the Union after a temporary export of less than 90 days is authorised is justified. It is therefore necessary to amend the model health certificate and the model declaration set out in Chapter 1 of Section B of Part 2 of Annex II to Implementing Regulation (EU) 2018/659. |
| --- | --- |

(4)

A new Show Jumping League has been established in the United Arab Emirates under the auspices of the Fédération Equestre Internationale (‘FEI’) which includes qualifying tests for the Show Jumping World Cup. Based on the animal health guarantees provided by the United Arab Emirates, adding the series of show jumping competitions of the United Arab Emirates International Show Jumping League to the list of events for which the re-entry into the Union after a temporary export of less than 90 days is authorised is justified. It is therefore necessary to amend the model health certificate and the model declaration set out in Chapter 1 of Section B of Part 2 of Annex II to Implementing Regulation (EU) 2018/659.

| (5) | Implementing Regulation (EU) 2018/659 should therefore be amended accordingly. |
| --- | --- |

(5)

Implementing Regulation (EU) 2018/659 should therefore be amended accordingly.

| (6) | In order to avoid a negative impact on trade, it is necessary to provide for a transitional period until 31 October 2020 during which animal health certificates issued in accordance with Implementing Regulation (EU) 2018/659, as amended by Implementing Regulation (EU) 2019/2147 (4), shall be accepted provided they are issued prior to 21 October 2020. |
| --- | --- |

(6)

In order to avoid a negative impact on trade, it is necessary to provide for a transitional period until 31 October 2020 during which animal health certificates issued in accordance with Implementing Regulation (EU) 2018/659, as amended by Implementing Regulation (EU) 2019/2147 (4), shall be accepted provided they are issued prior to 21 October 2020.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Implementing Regulation (EU) 2018/659 is amended as follows:

| (1) | In Annex I, the entry for Turkey is amended in accordance with Annex I to this Regulation. |
| --- | --- |

(1)

In Annex I, the entry for Turkey is amended in accordance with Annex I to this Regulation.

| (2) | In Annex II, Chapter 1 of Section B of Part 2 is replaced by the text set out in Annex II to this Regulation. |
| --- | --- |

(2)

In Annex II, Chapter 1 of Section B of Part 2 is replaced by the text set out in Annex II to this Regulation.

Article 2

Until 31 October 2020, Member States shall authorise the re-entry into the Union of registered horses accompanied by the relevant animal health certificate drawn up in accordance with the model health certificate set out in Chapter 1 of Section B of Part 2 of Annex II to Implementing Regulation (EU) 2018/659, as amended by Implementing Regulation (EU) 2019/2147, provided that the animal health certificate was issued prior to 21 October 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, 27 April 2020.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 268, 14.9.1992, p. 54.

1

(2)  
  OJ L 192, 23.7.2010, p. 1.

2

(3)  Commission Implementing Regulation (EU) 2018/659 of 12 April 2018 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (OJ L 110, 30.4.2018, p. 1).

3

(4)  Commission Implementing Regulation (EU) 2019/2147 of 28 November 2019 amending and correcting Implementing Regulation (EU) 2018/659 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (OJ L 325, 16.12.2019, p. 99).

4

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ANNEX I

In Annex I to Implementing Regulation (EU) 2018/659, in the list of third countries and parts of the territory of third countries from which the entry into the Union of consignments of equidae and of semen, ova and embryos of equidae is authorised, the entry for Turkey is replaced by the following:

| ‘TR | Turkey | TR-0 | Whole country | — | — | — | — | — | — | — | — | — | — | — | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| TR-1 | Provinces of Ankara, Edirne, Istanbul, Izmir, Kirklareli and Tekirdag | E | — | — | — | — | — | — | — | — | — | —’ | |

‘TR

Turkey

TR-0

Whole country

—

—

—

—

—

—

—

—

—

—

—

TR-1

Provinces of Ankara, Edirne, Istanbul, Izmir, Kirklareli and Tekirdag

E

—

—

—

—

—

—

—

—

—

—’

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ANNEX II

In Section B of Part 2 of Annex II to Implementing Regulation (EU) 2018/659, Chapter 1 is replaced by the following:

‘Chapter 1

Model health certificate and model declaration applicable to re-entry into the Union of registered horses for competition after temporary export for a period of not more than 90 days to participate in equestrian events organised under the auspices of the Fédération Equestre Internationale (FEI)

(Test event in preparation of the Olympic Games, Olympic Games, Paralympics, World Equestrian Games/World Championship, Asian Equestrian Games, American Equestrian Games (including the PanAmerican Games, South American Games, Central American and Caribbean Games), Endurance World Cup in United Arab Emirates, LG Global Champions Tour, United Arab Emirates International Show Jumping League)

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