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Document L:2022:166:FULL

Official Journal of the European Union, L 166, 22 June 2022


Display all documents published in this Official Journal
 

ISSN 1977-0677

Official Journal

of the European Union

L 166

European flag  

English edition

Legislation

Volume 65
22 June 2022


Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

Commission Implementing Regulation (EU) 2022/964 of 10 June 2022 granting a Union authorisation for the biocidal product family SOPUROXID ( 1 )

1

 

*

Commission Implementing Regulation (EU) 2022/965 of 21 June 2022 authorising the placing on the market of kernels from the edible variety of Jatropha curcas L. as a novel food and amending Implementing Regulation (EU) 2017/2470 ( 1 )

118

 

*

Commission Implementing Regulation (EU) 2022/966 of 21 June 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use, the specific labelling requirements and specifications of the novel food Calanus finmarchicus oil ( 1 )

125

 

 

DECISIONS

 

*

Council Decision (EU) 2022/967 of 13 June 2022 on the position to be taken on behalf of the European Union within the Association Council established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part, as regards the adoption of the EU-Republic of Moldova Association Agenda

130

 

*

Council Decision (EU) 2022/968 of 16 June 2022 appointing two members of the Court of Auditors

134

 

*

Council Decision (EU) 2022/969 of 16 June 2022 on the position to be taken on behalf of the European Union in the World Forum for Harmonization of Vehicle Regulations of the United Nations Economic Commission for Europe as regards the proposals for modifications to UN Regulations Nos 12, 13, 13-H, 22, 24, 48, 49, 51, 53, 54, 74, 79, 85, 86, 90, 100, 106, 109, 117, 127, 129, 131, 135, 136, 137, 141, 145, 148, 149, 150, 157 and 162, as regards the proposal for modifications to UN GTR No 2, as regards the proposal for a new UN Regulation on reverse warning, as regards the proposal for a new UN Global Technical Regulation on durability of pollution control devices for two- and three-wheelers, as regards the proposal for a new Consolidated Resolution concerning exhaust ultra-fine particle numbers measurement for heavy duty vehicles, and as regards the proposal for authorisation to develop Amendment 4 to UN GTR No 3

135

 

*

Council Decision (EU) 2022/970 of 16 June 2022 on the position to be taken on behalf of the European Union within the ACP-EU Committee of Ambassadors as regards the amendment of Decision No 3/2019 of the ACP-EU Committee of Ambassadors to adopt transitional measures pursuant to Article 95(4) of the ACP-EU Partnership Agreement

145

 

 

GUIDELINES

 

*

Guideline (EU) 2022/971 of the European Central Bank of 19 May 2022 on the Centralised Securities Database and the production of securities issues statistics and repealing Guideline 2012/689/EU (ECB/2012/21) and Guideline (EU) 2021/834 (ECB/2021/15) (ECB/2022/25)

147

 


 

(1)   Text with EEA relevance.

EN

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

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


II Non-legislative acts

REGULATIONS

22.6.2022   

EN

Official Journal of the European Union

L 166/1


COMMISSION IMPLEMENTING REGULATION (EU) 2022/964

of 10 June 2022

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

(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 1 September 2017, 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 ‘SOPUROXID’ of product-types 2, 3 and 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 case number BC-KV033704-17 in the Register for Biocidal Products.

(2)

‘SOPUROXID’ contains peracetic 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 27 August 2020, 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 31 March 2021, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘SOPUROXID’ 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 ‘SOPUROXID’ is a ‘biocidal product family’ within the meaning of Article 3(1), point (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 28 April 2021, 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 ‘SOPUROXID’.

(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-0026179-0000 is granted to SOPURA N.V. for the making available on the market and use of the biocidal product family ‘SOPUROXID’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 12 July 2022 until 30 June 2032.

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, 10 June 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 167, 27.6.2012, p. 1.

(2)  ECHA opinion of 4 March 2021 on the Union authorisation of ‘SOPUROXID’ (ECHA/BPC/279/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation


ANNEX

Summary of product characteristics for a biocidal product family

SOPUROXID

Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 3 - Veterinary hygiene (Disinfectants)

Product type 4 - Food and feed area (Disinfectants)

Authorisation number: EU-0026179-0000

R4BP asset number: EU-0026179-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name

SOPUROXID

1.2.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

PT04 - Food and feed area (Disinfectants)

1.3.   Authorisation holder

Name and address of the authorisation holder

Name

SOPURA

Address

rue de Trazegnies 199, 6180 COURCELLES Belgium

Authorisation number

EU-0026179-0000

R4BP asset number

EU-0026179-0000

Date of the authorisation

12 July 2022

Expiry date of the authorisation

30 June 2032

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

Rue de Trazegnies 199, 6180 COURCELLES Belgium


Name of manufacturer

SOPURA QUIMICA

Address of manufacturer

Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain

Location of manufacturing sites

Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain


Name of manufacturer

HYPRED SAS (KERSIA Group)

Address of manufacturer

55, Boulevard Jules Verger (BP 10180), 35803 DINARD France

Location of manufacturing sites

55, Boulevard Jules Verger (BP 10180), 35803 DINARD France

Niepruszewo, ul. Kasztanowa, 64-320 Buk Poland

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

Active substance

Peracetic acid

Name of manufacturer

SOPURA N.V.

Address of manufacturer

Rue de Trazegnies 199, 6180 COURCELLES Belgium

Location of manufacturing sites

Rue de Trazegnies 199, 6180 COURCELLES Belgium


Active substance

Peracetic acid

Name of manufacturer

SOPURA QUIMICA

Address of manufacturer

Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain

Location of manufacturing sites

Poligon "La Canaleta", Avinguda Júpiter 7, 25300 TARREGA Spain


Active substance

Peracetic acid

Name of manufacturer

HYPRED SAS (KERSIA Group)

Address of manufacturer

55, Boulevard Jules Verger (BP 10180), 35803 DINARD France

Location of manufacturing sites

55, Boulevard Jules Verger (BP 10180), 35803 DINARD France

Niepruszewo, ul. Kasztanowa, 64-320 Buk Poland

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

Peracetic acid

 

Active Substance

79-21-0

201-186-8

3,2

15,0

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

0,2

24,04

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

16,5

23,5

Acetic acid

 

Non-active substance

64-19-7

200-580-7

5,5

16,7

2.2.   Type(s) of formulation

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 SPC1

1.2.   Suffix to the authorisation number

Number

1-1

1.3.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

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

Peracetic acid

 

Active Substance

79-21-0

201-186-8

5,0

5,0

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

0,2

24,04

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

16,5

22,0

Acetic acid

 

Non-active substance

64-19-7

200-580-7

5,5

9,55

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

Formulation(s)

SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

May intensify fire; oxidiser

May be corrosive to metals.

Harmful if swallowed. Harmful in contact with skin. Harmful if inhaled.

Causes severe skin burns and eye damage.

Causes serious eye damage.

May cause respiratory irritation.

Very toxic to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Wear protective gloves.

Wear eye protection.

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/doctor.

Take any precaution to avoid mixing with combustibles.

Avoid breathing vapours.

Wash hands thoroughly after handling.

Do not eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Specific treatment (see information on this label).

Rinse mouth.

Wash contaminated clothing before reuse.

IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

IF ON SKIN: Wash with plenty of water.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

Take off immediately all contaminated clothing. And wash it before reuse.

Store locked up.

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

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

Wear protective clothing.

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

Keep cool.

Avoid release to the environment.

Collect spillage.

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

Avoid breathing spray.

Do not breathe spray.

Do not breathe vapours.

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

4.1.   Use description

Table 1

Use # 1 – Disinfection of surfaces in industrial, public and non-medical healthcare areas - manual treatment (mopping)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In Industrial, public and non-medical healthcare areas:

Disinfection of hard/non-porous surfaces by manual treatment (mopping) with prior cleaning

Application method(s)

Method: Manual treatment (mopping).

Detailed description:

Diluted product is applied by mopping with the appropriate tool (e.g. flat mop or cleaning cloths).

After application, the diluted product is drained.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2 Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.1.1.   Use-specific instructions for use

Items to be disinfected by mopping have to stay sufficiently wet during the required contact time to allow optimal disinfection.

4.1.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing and loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Re-entry is only permitted once the air concentrations of peracetic acid and hydrogen peroxide have dropped below the respective reference values (AEC). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment (specified by the authorization holder).

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 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. - manual treatment (spraying)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In Industrial, public and non-medical healthcare areas:

Disinfection of hard/non-porous surfaces by manual treatment (spraying) with prior cleaning

Application method(s)

Method: Manual treatment (spraying)

Detailed description:

Diluted product is applied by spraying using a small spraying can

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2. Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.2.1.   Use-specific instructions for use

See general directions for use

4.2.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

“The treated surface should not be allowed to dry prior to rinsing.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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 3

Use # 3 – Clean in Place (CIP) in the pharmaceutical and cosmetic industry

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In pharmaceutical and cosmetic industry:

Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning

Application method(s)

Method: By CIP procedure

Detailed description:

Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.

After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0,032 % PAA (Dilution of the product at 0,64 % i.e. 640 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.3.1.   Use-specific instructions for use

See general directions for use

4.3.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Rinse the pump and disconnect it from the installation before maintenance”

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 4

Use # 4 – Surface disinfection in greenhouses via spraying by user with personal enclosure (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In greenhouses:

Disinfection of hard/non-porous surfaces by spraying

Application method(s)

Method: Open system: spray treatment

Detailed description:

Diluted product is automatically applied in all directions via a spraying device

The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.4.1.   Use-specific instructions for use

See general directions for use.

4.4.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.5.   Use description

Table 5

Use # 5 – Surface disinfection in greenhouses via spraying by user without personal enclosure (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In greenhouses:

Disinfection of hard/non-porous surfaces by spraying

Application method(s)

Method: Open system: spray treatment

Detailed description:

Diluted product is automatically applied in all directions via a spraying device.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.5.1.   Use-specific instructions for use

See general directions for use.

4.5.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.6.   Use description

Table 6

Use # 6 – Disinfection of agriculture & horticulture equipment by soaking (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning.

Application method(s)

Method: Open system: immersion

Detailed description:

The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.6.1.   Use-specific instructions for use

See general directions for use.

4.6.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.7.   Use description

Table 7

Use # 7 – Disinfection of surfaces and agriculture/horticulture equipment by spraying (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Open system: spray treatment

Detailed description:

The diluted product is manually sprayed on the surfaces/equipment using spraying equipment. Spraying is only applied downwards and in a horizontal direction.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.7.1.   Use-specific instructions for use

See general directions for use.

4.7.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.8.   Use description

Table 8

Use # 8 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

Diluted product is applied by spraying in an automated way

Spraying is only applied downwards and in a horizontal direction.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.8.1.   Use-specific instructions for use

See general directions for use.

4.8.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.8.3.   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.

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

See general directions for use.

4.8.5.   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.

4.9.   Use description

Table 9

Use # 9 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (closed room) (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: By spraying.

Detailed description:

Diluted product is applied by spraying in an automated way without any operator being present

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.9.1.   Use-specific instructions for use

See general directions for use.

4.9.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.9.3.   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.

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

See general directions for use.

4.9.5.   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.

4.10.   Use description

Table 10

Use # 10 – Disinfection of animal housing – via low-pressure spraying by user with personal enclosure

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

In animal housing:

Disinfection of hard/non-porous surfaces by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

Diluted product is automatically applied in all directions by low-pressure manual spraying via a spraying device

The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)

Application rate(s) and frequency

Application Rate: Between 20 and 300 mL/m2

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.10.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.

4.10.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.10.3.   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.

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

See general directions for use.

4.10.5.   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.

4.11.   Use description

Table 11

Use # 11 – Disinfection of animal housing via low-pressure manual spraying by user without personal enclosure

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

In animal housing:

Disinfection of hard/non-porous surfaces by spraying with prior cleaning

Application method(s)

Method: Open system: spray treatment

Detailed description:

Diluted product is automatically applied in all directions by low-pressure automatic spraying via a spraying device

Application rate(s) and frequency

Application Rate: Between 20 and 300 mL/m2

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e.1 280 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.11.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.

4.11.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.11.3.   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.

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

See general directions for use.

4.11.5.   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.

4.12.   Use description

Table 12

Use # 12 – Disinfection of boots in footbaths in animal housing/husbandries

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

in animal housing/husbandries:

Disinfection of boots by dipping (not for walk-through) with prior cleaning.

Application method(s)

Method: Dipping

Detailed description:

Diluted product is put in the footbath

No rinse needed

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.12.1.   Use-specific instructions for use

See general directions for use.

4.12.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.12.3.   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.

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

See general directions for use.

4.12.5.   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.

4.13.   Use description

Table 13

Use # 13 – Disinfection of equipment by dipping

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning

Application method(s)

Method: Soaking.

Detailed description:

The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.13.1.   Use-specific instructions for use

See general directions for use.

4.13.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance

4.13.3.   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.

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

See general directions for use.

4.13.5.   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.

4.14.   Use description

Table 14

Use # 14 – Disinfection in Aseptic Filling Lines (crown corks, cheese moulds and food crates) - Automated spraying closed systems

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food and beverage industry:

Disinfection of hard/non-porous surfaces by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

Diluted product is sprayed on the surfaces in an automated way without any operator being present

Application rate(s) and frequency

Application Rate: -

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.14.1.   Use-specific instructions for use

See general directions for use.

4.14.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance

The treated surface should not be allowed to dry prior to rinsing.

4.14.3.   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.

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

See general directions for use.

4.14.5.   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.

4.15.   Use description

Table 15

Use # 15 – Disinfection of equipment in the food and beverage industry by immersion

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food and beverage industry:

Disinfection of hard/non-porous surfaces (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning

Application method(s)

Method: Soaking.

Detailed description:

The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected

Application rate(s) and frequency

Application Rate: -

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.15.1.   Use-specific instructions for use

See general directions for use.

4.15.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.15.3.   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.

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

See general directions for use.

4.15.5.   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.

4.16.   Use description

Table 16

Use # 16 – Disinfection of heat and ion exchangers, membrane filters and glass and PET bottles – CIP procedures

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food and beverage industry:

Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning

Application method(s)

Method: Closed system

Detailed description:

Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.

After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.

Application rate(s) and frequency

Application Rate: -

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.16.1.   Use-specific instructions for use

See general directions for use.

4.16.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Rinse the pump and disconnect it from the installation before maintenance

4.16.3.   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.

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

See general directions for use.

4.16.5.   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.

4.17.   Use description

Table 17

Use # 17 – Disinfection of surfaces and equipment by low pressure spraying – spraying with personal enclosure

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device

The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device).

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.17.1.   Use-specific instructions for use

See general directions for use.

4.17.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.17.3.   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.

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

See general directions for use.

4.17.5.   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.

4.18.   Use description

Table 18

Use # 18 – Disinfection of surfaces and equipment by low pressure spraying – spraying without personal enclosure

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.18.1.   Use-specific instructions for use

See general directions for use.

4.18.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance

The treated surface should not be allowed to dry prior to rinsing.

4.18.3.   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.

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

See general directions for use.

4.18.5.   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.

4.19.   Use description

Table 19

Use # 19 – Disinfection of surfaces and equipment by low pressure spraying, manually

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Manual application - spraying.

Detailed description:

Diluted product is manually applied by low-pressure spraying, only downwards and horizontal.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.19.1.   Use-specific instructions for use

See general directions for use.

4.19.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.19.3.   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.

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

See general directions for use.

4.19.5.   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.

4.20.   Use description

Table 20

Use # 20 – Disinfection of surfaces and equipment by low pressure spraying, automatically

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

The diluted product is sprayed on the equipment, on conveyor belt, automatically.

The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device).

Spraying is only applied downwards and in a horizontal direction.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.20.1.   Use-specific instructions for use

See general directions for use.

.

4.20.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

RPE are not mandatory during the application phase, on the condition that the operator remains in the control room and do not enter the treated area.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.20.3.   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.

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

See general directions for use.

4.20.5.   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.

4.21.   Use description

Table 21

Use # 21 – Disinfection of surfaces and equipment by low pressure spraying – automatic spraying (closed room)

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

The diluted solution is sprayed on the surfaces in an automated way without any user being present.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.21.1.   Use-specific instructions for use

See general directions for use.

4.21.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) is not mandatory during the application phase, on condition that the operator do not enter the treated area and remains in the control room.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.21.3.   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.

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

See general directions for use.

4.21.5.   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.

4.22.   Use description

Table 22

Use # 22 – Disinfection of inner surfaces (pipelines, tanks, vessels, …) by CIP

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning

Application method(s)

Method: Closed system

Detailed description:

Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.

After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.

Application rate(s) and frequency

Application Rate: -

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0,96 % i.e. 960 mL/100 L) in 15 min contact time , efficient use temperature from + 4 °C up to Room Temperature. - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 1,28 % i.e. 1 280 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature. For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.22.1.   Use-specific instructions for use

See general directions for use.

4.22.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading phase.

Respiratory protection:

Rinse the pump and disconnect it from the installation before maintenance”

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

4.22.3.   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.

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

See general directions for use.

4.22.5.   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.

4.23.   Use description

Table 23

Use # 23 – Disinfection of water used for rinsing of recycled items during the washing process

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of water (in clean conditions) used for rinsing of recycled items = Water from drinking water quality shortly stored in tanks until use to rinse items such as bottles. The water should be disinfected to avoid recontamination and in an extent to avoid cross-contamination of inner bottle surfaces

Application method(s)

Method: Closed system

Detailed description:

Concentrated product will be pumped into a reservoir from which it is continuously dosed into the water stream.

Dilution of the product to the intended in-use concentration occurs in the water stream.

This application is a closed, automated process.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0.008 % PAA (Dilution of the product at 0.16 % i.e. 160 mL/100 L) at Room Temperature in 15 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.23.1.   Use-specific instructions for use

See general directions for use.

4.23.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection: Not mandatory.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

4.23.3.   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.

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

See general directions for use.

4.23.5.   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

1.

All the surfaces to be disinfected must be cleaned before the disinfection procedure

2.

Disinfection cycle:

Products must be diluted in potable water before use.

Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use.

Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use.

Only for use in areas that are inaccessible to the general public and companion animals.

No access for the general public during treatment.

Disinfection procedures by CIP: Final rinsing step (with potable water).

After the disinfection procedure, CIP vessels (pipework and tanks) are drained and rinsed with water under closed system conditions

Disinfection procedures by dipping: The bath is not intended to be re-used. Use the bath only once a day after work & replace it by a fresh solution daily.

Disinfection procedures by spraying: the surfaces to be disinfected must be wet enough in order to keep them wet during the required contact time for optimal disinfection. Then, the user should pay attention to wet surfaces completely with the disinfectant solution.

The Application Rate for spraying of diluted product must be between 20 and 30 mL/m2

5.2.   Risk mitigation measures

Dermal protection:

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).

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

Indirect effects

The two theoretical products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion.

Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self-accelerated, exothermic decomposition and the formation of oxygen.

In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst.

First aid measures

Ø   General advice

Move out of dangerous area.

Take care of your own personal safety.

Take off immediately all contaminated clothing.

Ø   Inhalation

Take affected persons out into the fresh air.

Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.

If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately.

Ø   Skin contact

After contact with skin, wash immediately with plenty of water.

Consult a physician.

Take off immediately all contaminated clothing.

Immediately rinse contaminated or saturated clothing with water.

Ø   Eye contact

With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.

Protect unharmed eye.

Continue rinsing process with eye rinsing solution.

Call ambulance (caustic burn of the eyes)

Immediate further treatment in ophthalmic hospital/ophthalmologist.

Continue rinsing eye until arrival at ophthalmic hospital.

Ø   Ingestion

Do not induce vomiting.

Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation.

Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest.

Notify ambulance immediately (key word: acid burn).

Ø   Notes to physician

Therapy as for chemical burn.

Following inhalation:

Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area).

Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone).

If substance has been swallowed:

Aspiration hazard.

Risk of gaseous embolisms.

In case of excessive strain on the stomach due to gas evolution, insert siphon tube.

Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear.

If necessary, suck away leftover substance.

Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide.

Emergency measures to protect the environment

Observe regulations on prevention of water pollution (collect, dam up, cover up).

Do not allow to run into water channels, surface water or into the ground.

Ø   Methods for cleaning up

Clean contaminated surface thoroughly; recommended cleaning agent is water.

In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.

Ø   Additional advice

Make safe or remove all sources of ignition.

Isolate defective containers immediately, if possible and safe to do.

Shut off leak, if possible and safe to do.

Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal).

Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition).

Product taken out should not be returned into container.

Never return spilled product into its original container for re-use (risk of decomposition).

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

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition

The shelf life of the biocidal product is 6 months.

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

6.   OTHER INFORMATION

Reference values of peracetic acid and hydrogen peroxide used for the risk assessment:

PAA: AECinhal = 0,5 mg/m3

HP: AECinhal = 1,25 mg/m3

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)

SOPUROXID 5

Market area: EU

 

HyPro Biocide 5-22

Market area: EU

AGRIOXID 5

Market area: EU

TECMA CUAR HPA

Market area: EU

Authorisation number

EU-0026179-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Peracetic acid

 

Active Substance

79-21-0

201-186-8

5,0

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

0,2

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

22,0

Acetic acid

 

Non-active substance

64-19-7

200-580-7

9,55

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

Trade name(s)

SOPUROXID 5C

Market area: EU

 

DEPTIL TR 5

Market area: EU

DIS OXI-5+

Market area: EU

ANTI-GERM DES OXI-50 TC

Market area: EU

Peracid ATR +

Market area: EU

FOR-Acid TR +

Market area: EU

X-CID TR 50 +

Market area: EU

Authorisation number

EU-0026179-0002 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Peracetic acid

 

Active Substance

79-21-0

201-186-8

5,0

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

24,04

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

16,5

Acetic acid

 

Non-active substance

64-19-7

200-580-7

5,8

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

Meta SPC2

1.2.   Suffix to the authorisation number

Number

1-2

1.3.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 - Food and feed area (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 2 COMPOSITION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Peracetic acid

 

Active Substance

79-21-0

201-186-8

3,2

3,2

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

0,8

1,0

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

23,5

23,5

Acetic acid

 

Non-active substance

64-19-7

200-580-7

6,45

7,5

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

Formulation(s)

SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements

May intensify fire; oxidiser

May be corrosive to metals.

Causes severe skin burns and eye damage.

Causes serious eye damage.

May cause respiratory irritation.

Very toxic to aquatic life with long lasting effects.

Harmful if swallowed. Harmful in contact with skin.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

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/doctor.

Wear eye protection.

Wear protective gloves.

Take any precaution to avoid mixing with combustibles.

Avoid breathing vapours.

Wash hands thoroughly after handling.

Do not eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Specific treatment (see information on this label).

Rinse mouth.

Wash contaminated clothing before reuse.

IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

IF ON SKIN: Wash with plenty of water.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

Take off contaminated clothing. And wash it before reuse.

Store locked up.

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

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

Wear protective clothing.

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

Keep cool.

Avoid release to the environment.

Collect spillage.

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

Avoid breathing spray.

Do not breathe spray.

Do not breathe vapours.

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

4.1.   Use description

Table 24

Use # 1 – Room Disinfection by fogging - In industrial, public and non-medical healthcare areas. (pharmaceutical and cosmetic industry)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Field(s) of use

Indoor

In industrial, public and non-medical healthcare areas:

Disinfection of hard/non-porous surfaces by fogging.

Application method(s)

Method: Fogging

Detailed description:

By fogging with the diluted product

Application rate(s) and frequency

Application Rate: -

Dilution (%): Active against bacteria (including bacterial spores) and yeasts: With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion)

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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 25

Use # 2 – Room Disinfection by fogging - In agriculture & horticulture areas (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces by fogging with prior cleaning

Application method(s)

Method: Fogging

Detailed description:

By fogging with the diluted product

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion)

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.2.1.   Use-specific instructions for use

See general directions for use.

4.2.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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 26

Use # 3 – Room Disinfection by fogging – In animal housing

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In animal housing:

Disinfection of hard/non-porous surfaces by fogging with prior cleaning

Application method(s)

Method: Fogging

Detailed description:

By fogging with the diluted product

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion)

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.3.1.   Use-specific instructions for use

See general directions for use.

4.3.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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 27

Use # 4 – Room Disinfection by fogging – In storage rooms with special device in storage cellar or room

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

..

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Field(s) of use

Indoor

In food/feed areas (storage rooms):

Disinfection of hard/non-porous surfaces by fogging.

Application method(s)

Method: Fogging

Detailed description:

By fogging with the diluted product

Application rate(s) and frequency

Application Rate: -

Dilution (%): Active against bacteria (including bacterial spores) and yeasts With 5,6 mL/m3 (Dilution of the product at 40 % i.e. 40 L/100 L i.e. 1,28 % PAA) at Room Temperature in 2h contact time (after diffusion)

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.4.1.   Use-specific instructions for use

See general directions for use.

4.4.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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

1.

All the surfaces to be disinfected must be cleaned before the disinfection procedure.

For exceptions, please refer to the description of application method related to each use.

2.

Disinfection cycle:

Products must be diluted in potable water before use.

Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use.

Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use.

Meta SPC2: Disinfection procedures by fogging

The product SOPUROXID 3.2 is a liquid disinfectant to be applied (after dilution at 40 %) by fogging for airborne surface disinfection and to be used indoor by professional users only.

Always check compatibility of the products with the hard/non-porous surfaces to be disinfected.

The product SOPUROXID 3.2 has been developed and demonstrated as efficacious (via efficacy studies performed according to the NF T 72 281 standard), using one device HYSPRAY, for rooms with a volume between 30 & 150 m3 (volume per application and per device) with a flow rate of 0,047 mL/min/m3.

The use of other devices is possible. They must be designed to work with PAA-based products and to ensure a fog production able to stay suspended in the air and provided that these devices meet following characteristics:

1)

Particle (medium droplet) size: between 1 and 15 μm

2)

Flow rate: 0,047 mL/min/m3

3)

Application rate: 5,6 mL/m3

4)

Room volume between 30 and 150 m3 per application and per device (i.e. diffusion time between 5 and 30 min)

Airborne disinfection should be done only after thorough cleaning and rinsing.

The surfaces to be disinfected should be dried before the disinfection procedure. Please pay attention to open the cupboard doors. Please check the temperature and the relative room humidity (to be set between 40 and 80 %) to obtain an optimal level for the product efficiency.

The room where the fogging activity takes place is tightly sealed during fogging, no user is present:

Before the start of the disinfection cycle by fogging, the treated room is sealed. All the safety tasks for the implementation of decontamination are entrusted to an user who has completed the necessary training. Among them, first step is shutting down the air handling units and closing the air intake and return, so the product is not spread in the other rooms. The door or doors to the outside of the area are then locked and, if the joints are not tight enough, they are taped to seal. An orange tape, or bright colour, is preferably chosen to attract attention and a sign "Access ban, room disinfection in progress" is put on. Only for use in areas that are inaccessible to the general public and companion animals”.

The user shall always carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable "standard room", if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. Each device or specific installation is systematically validated when it is set up.

5.2.   Risk mitigation measures

Dermal protection:

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).

+ Additional specific RMM for fogging applications:

 

Only for use in areas that are inaccessible to the general public and companion animals.

After disinfection product’s application by fogging & required contact time for optimal disinfection (2h), the room must be ventilated, preferably by mechanical ventilation at least for 60 min.

The duration of the ventilation period has to be established by measurement with suitable measurement equipment (specified by the authorisation holder within the product information).

After ventilation, re-entry in the disinfected area is only permitted after the air concentrations of peracetic acid and hydrogen peroxide have been checked and seen as dropped below the respective reference values (AEC):

The air concentration of PAA must have dropped to 0,5 mg/m3.

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

Indirect effects

The two products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion.

Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self-accelerated, exothermic decomposition and the formation of oxygen.

In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst.

First aid measures

Ø   General advice

Move out of dangerous area.

Take care of your own personal safety.

Take off immediately all contaminated clothing.

Ø   Inhalation

Take affected persons out into the fresh air.

Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.

If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately.

Ø   Skin contact

After contact with skin, wash immediately with plenty of water.

Consult a physician.

Take off immediately all contaminated clothing.

Immediately rinse contaminated or saturated clothing with water.

Ø   Eye contact

With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.

Protect unharmed eye.

Continue rinsing process with eye rinsing solution.

Call ambulance (caustic burn of the eyes)

Immediate further treatment in ophthalmic hospital/ophthalmologist.

Continue rinsing eye until arrival at ophthalmic hospital.

Ø   Ingestion

Do not induce vomiting.

Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation.

Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest.

Notify ambulance immediately (key word: acid burn).

Ø   Notes to physician

Therapy as for chemical burn.

Following inhalation:

Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area).

Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone).

If substance has been swallowed:

Aspiration hazard.

Risk of gaseous embolisms.

In case of excessive strain on the stomach due to gas evolution, insert siphon tube.

Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear.

If necessary, suck away leftover substance.

Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide.

Emergency measures to protect the environment

Observe regulations on prevention of water pollution (collect, dam up, cover up).

Do not allow to run into water channels, surface water or into the ground.

Ø   Methods for cleaning up

Clean contaminated surface thoroughly; recommended cleaning agent is water.

In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.

Ø   Additional advice

Make safe or remove all sources of ignition.

Isolate defective containers immediately, if possible and safe to do.

Shut off leak, if possible and safe to do.

Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal).

Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition).

Product taken out should not be returned into container.

Never return spilled product into its original container for re-use (risk of decomposition).

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

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition

The shelf life of the biocidal product is 6 months.

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

6.   OTHER INFORMATION

Reference values of peracetic acid and hydrogen peroxide used for the risk assessment:

PAA: AECinhal = 0,5 mg/m3

HP: AECinhal = 1,25 mg/m3

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)

SOPUROXID 3.2

Market area: EU

 

HyPro Biocide 3.2-23

Market area: EU

Authorisation number

EU-0026179-0003 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Peracetic acid

 

Active Substance

79-21-0

201-186-8

3,2

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

0,8

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

23,5

Acetic acid

 

Non-active substance

64-19-7

200-580-7

6,45

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier

Meta SPC3

1.2.   Suffix to the authorisation number

Number

1-3

1.3.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 - Food and feed area (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 3 COMPOSITION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Peracetic acid

 

Active Substance

79-21-0

201-186-8

3,2

3,2

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

0,6

1,0

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

23,5

23,5

Acetic acid

 

Non-active substance

64-19-7

200-580-7

5,5

7,1

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

Formulation(s)

SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements

May intensify fire; oxidiser

May be corrosive to metals.

Harmful if swallowed. Harmful in contact with skin.

Causes severe skin burns and eye damage.

Causes serious eye damage.

May cause respiratory irritation.

Very toxic to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Wear protective gloves.

Wear face protection.

Wear eye 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/doctor.

Take any precaution to avoid mixing with combustibles.

Avoid breathing vapours.

Wash hands thoroughly after handling.

Do not eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Specific treatment (see information on this label).

Rinse mouth.

Wash contaminated clothing before reuse.

IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.

IF ON SKIN: Wash with plenty of water.

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

Take off immediately all contaminated clothing. And wash it before reuse.

Store locked up.

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

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

Wear protective clothing.

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

Keep cool.

Avoid release to the environment.

Collect spillage.

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

Avoid breathing spray.

Do not breathe vapours.

Do not breathe vapours.

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

4.1.   Use description

Table 28

Use # 1 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. – foam application on surfaces

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In industrial, public and non-medical healthcare areas:

Disinfection of hard/non-porous surfaces by foaming with prior cleaning

Application method(s)

Method: Foam application

Detailed description:

By foaming via a small foaming can with the diluted product

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1500 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2 Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2.   Use description

Table 29

Use # 2 – Disinfection of surfaces and agriculture/horticulture equipment by foaming, manually (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment by foaming with prior cleaning

Application method(s)

Method: Foam application

Detailed description:

By foaming via a small foaming can with the diluted product

Foaming is only applied downwards and in a horizontal direction.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.2.1.   Use-specific instructions for use

See general directions for use.

4.2.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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 30

Use # 3 – Disinfection of surfaces and agriculture/horticulture equipment by automatic foaming (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment by automatic foaming with prior cleaning

Application method(s)

Method: Foam application

Detailed description:

The diluted product is foamed on the equipment in an automated way while the user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device).

Foaming is only applied downwards and in a horizontal direction.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.3.1.   Use-specific instructions for use

See general directions for use.

4.3.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

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 31

Use # 4 – Disinfection of surfaces and agriculture/horticulture equipment by automatic foaming (closed rooms) (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment by automatic foaming with prior cleaning

Application method(s)

Method: Foam application

Detailed description:

The diluted product is foamed on the surfaces in an automated way without any user being present.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.4.1.   Use-specific instructions for use

See general directions for use.

4.4.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.5.   Use description

Table 32

Use # 5 – Disinfection of animal houses by foaming – foaming with personal enclosure

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

In animal housing

Disinfection of hard/non-porous surfaces by foaming with prior cleaning

Application method(s)

Method: Foam application

Detailed description:

The diluted product is automatically foamed in all directions on the surfaces/walls, via a foaming device.

The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.5.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.

4.5.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading and of a factor of 10 during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.6.   Use description

Table 33

Use # 6 – Disinfection of animal houses by foaming – foaming without personal enclosure

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

In animal housing

Disinfection of hard/non-porous surfaces by foaming with prior cleaning

Application method(s)

Method: Foam application

Detailed description:

The diluted product is automatically foamed on the surfaces/walls, in all directions, via a foaming device.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.6.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.

4.6.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.7.   Use description

Table 34

Use # 7 – Disinfection of surfaces by foaming – foaming with personal enclosure

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces by foaming with prior cleaning

Application method(s)

Method: Foam application

Detailed description:

The diluted product is automatically foamed on the surfaces/walls, in all directions, via a foaming device.

The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria & yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Against bacteria (including bacterial spores), yeasts and viruses (including bacteriophages): With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000 mL/100 L) at Room Temperature in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.7.1.   Use-specific instructions for use

See general directions for use.

4.7.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Respiratory protection with an APF of 10 is required during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.8.   Use description

Table 35

Use # 8 – Disinfection of surfaces by foaming – without personal enclosure

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

Indoor – In food industry:

Disinfection of hard/non-porous surfaces by foaming with prior cleaning

Application method(s)

Method: Foam application

Detailed description:

The diluted product is automatically foamed on the surfaces/walls, in all directions, via a foaming device.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria & yeasts: With 0,048 % PAA (Dilution of the product at 1.5 % i.e. 1 500 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Against bacteria (including bacterial spores), yeasts and viruses (including bacteriophages): With 0,064 % PAA (Dilution of the product at 2 % i.e. 2 000 mL/100 L) at Room Temperature in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.8.1.   Use-specific instructions for use

See general directions for use.

4.8.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.8.3.   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.

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

See general directions for use.

4.8.5.   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

1.

All the surfaces to be disinfected must be cleaned before the disinfection procedure

2.

Disinfection cycle:

Products must be diluted in potable water before use.

Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use.

Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use.

Meta SPC 3: Disinfection procedures by foaming

Only for use in areas that are inaccessible to the general public and companion animals.

No access for the general public during treatment.

The surfaces to be disinfected must be wet enough in order to keep them wet during the required contact time for optimal disinfection. Then, the user should pay attention to wet surfaces completely with the disinfectant solution.

5.2.   Risk mitigation measures

Dermal protection:

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).

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

Indirect effects

The two products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion.

Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self-accelerated, exothermic decomposition and the formation of oxygen.

In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst.

First aid measures

Ø   General advice

Move out of dangerous area.

Take care of your own personal safety.

Take off immediately all contaminated clothing.

Ø   Inhalation

Take affected persons out into the fresh air.

Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.

If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately.

Ø   Skin contact

After contact with skin, wash immediately with plenty of water.

Consult a physician.

Take off immediately all contaminated clothing.

Immediately rinse contaminated or saturated clothing with water.

Ø   Eye contact

With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.

Protect unharmed eye.

Continue rinsing process with eye rinsing solution.

Call ambulance (caustic burn of the eyes)

Immediate further treatment in ophthalmic hospital/ophthalmologist.

Continue rinsing eye until arrival at ophthalmic hospital.

Ø   Ingestion

Do not induce vomiting.

Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation.

Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest.

Notify ambulance immediately (key word: acid burn).

Ø   Notes to physician

Therapy as for chemical burn.

Following inhalation:

Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area).

Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone).

If substance has been swallowed:

Aspiration hazard.

Risk of gaseous embolisms.

In case of excessive strain on the stomach due to gas evolution, insert siphon tube.

Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear.

If necessary, suck away leftover substance.

Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide.

Emergency measures to protect the environment

Observe regulations on prevention of water pollution (collect, dam up, cover up).

Do not allow to run into water channels, surface water or into the ground.

Ø   Methods for cleaning up

Clean contaminated surface thoroughly; recommended cleaning agent is water.

In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.

Ø   Additional advice

Make safe or remove all sources of ignition.

Isolate defective containers immediately, if possible and safe to do.

Shut off leak, if possible and safe to do.

Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal).

Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition).

Product taken out should not be returned into container.

Never return spilled product into its original container for re-use (risk of decomposition).

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

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition

The shelf life of the biocidal product is 6 months.

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

6.   OTHER INFORMATION

Reference values of peracetic acid and hydrogen peroxide used for the risk assessment:

PAA: AECinhal = 0,5 mg/m3

HP: AECinhal = 1,25 mg/m3

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)

ACIDOFOAM CF

Market area: EU

 

HyPro Biocide 3.2-23a

Market area: EU

TECHMA OXI PB

Market area: EU

Authorisation number

EU-0026179-0004 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Peracetic acid

 

Active Substance

79-21-0

201-186-8

3,2

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

0,8

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

23,5

Acetic acid

 

Non-active substance

64-19-7

200-580-7

6,1

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier

Meta SPC4

1.2.   Suffix to the authorisation number

Number

1-4

1.3.   Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT03 - Veterinary hygiene (Disinfectants)

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

Peracetic acid

 

Active Substance

79-21-0

201-186-8

15,0

15,0

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

0,78

0,78

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

22,0

22,0

Acetic acid

 

Non-active substance

64-19-7

200-580-7

16,7

16,7

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

Formulation(s)

SL - Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements

Heating may cause a fire.

May be corrosive to metals.

Harmful if swallowed. Harmful if inhaled.

Causes severe skin burns and eye damage.

Causes serious eye damage.

May cause respiratory irritation.

Very toxic to aquatic life with long lasting effects.

Flammable liquid and vapour.

Toxic in contact with skin.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Wear protective gloves.

Wear eye protection.

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/doctor.

Take any precaution to avoid mixing with combustibles.

Avoid breathing vapours.

Wash hands thoroughly after handling.

Do not eat, drink or smoke when using this product.

Use only outdoors or in a well-ventilated area.

Specific treatment (see information on this label).

Rinse mouth.

Wash contaminated clothing before reuse.

IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

IF ON SKIN: Wash with plenty of water.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

Take off immediately all contaminated clothing. And wash it before reuse.

Store locked up.

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

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

Wear protective clothing.

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

Keep cool.

Avoid release to the environment.

Collect spillage.

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

Do not breathe spray.

Avoid breathing spray.

Do not breathe vapours.

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

4.1.   Use description

Table 36

Use # 1 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. - manual treatment (mopping)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In Industrial, public and non-medical healthcare areas:

Disinfection of hard/non-porous surfaces by manual treatment (mopping) with prior cleaning

Application method(s)

Method: Manual treatment (mopping).

Detailed description:

Diluted product is applied by mopping with the appropriate tool (e.g. flat mops or cleaning cloths).

After application, the diluted product is drained.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2. Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.1.1.   Use-specific instructions for use

Items to be disinfected by mopping have to stay sufficiently wet during the required contact time to allow optimal disinfection.

4.1.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

Re-entry is only permitted once the air concentrations of peracetic acid and hydrogen peroxide have dropped below the respective reference values (AEC). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment (specified by authorization holder).

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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 37

Use # 2 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. - manual treatment (spraying)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In Industrial, public and non-medical healthcare areas:

Disinfection of hard/non-porous surfaces by manual treatment (spraying) with prior cleaning

Application method(s)

Method: Manual treatment (spraying)

Detailed description:

Diluted product is applied by spraying using a small spraying can.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: Non-medical healthcare areas With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) at Room Temperature in 5 min contact time. Application rate: 20 mL/m2. Use other than in HEALTHCARE With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature. Application rate: 30 mL/m2.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.2.1.   Use-specific instructions for use

See general directions for use.

4.2.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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 38

Use # 3 – Clean in Place (CIP) in the pharmaceutical and cosmetic industry

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In pharmaceutical and cosmetic industry:

Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning

Application method(s)

Method: By CIP procedure

Detailed description:

Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.

After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria & yeasts: With 0,032 % PAA (Dilution of the product at 0.2133 % i.e.213.33 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.3.1.   Use-specific instructions for use

See general directions for use.

4.3.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Rinse the pump and disconnect it from the installation before maintenance.

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 39

Use # 4 – Surface disinfection in greenhouses via spraying by user with personal enclosure (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In greenhouses:

Disinfection of hard/non-porous surfaces by spraying with prior cleaning

Application method(s)

Method: Open system: spray treatment

Detailed description:

Diluted product is automatically applied in all directions by spraying via a spraying device

The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.4.1.   Use-specific instructions for use

See general directions for use.

4.4.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.5.   Use description

Table 40

Use # 5 – Surface disinfection in greenhouses via spraying by user without personal enclosure (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In greenhouses:

Disinfection of hard/non-porous surfaces by spraying with prior cleaning

Application method(s)

Method: Open system: spray treatment

Detailed description:

Diluted product is automatically applied in all directions by spraying via a spraying device.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.5.1.   Use-specific instructions for use

See general directions for use.

4.5.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.6.   Use description

Table 41

Use # 6 – Disinfection of agriculture & horticulture equipment by soaking (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning

Application method(s)

Method: Open system: immersion

Detailed description:

The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.6.1.   Use-specific instructions for use

See general directions for use.

4.6.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.7.   Use description

Table 42

Use # 7 – Disinfection of surfaces and agriculture/horticulture equipment by spraying (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Open system: spray treatment

Detailed description:

The diluted product is manually sprayed on the surfaces/equipment using spraying equipment. Spraying is only applied downwards and in a horizontal direction.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.7.1.   Use-specific instructions for use

See general directions for use.

4.7.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance

“The treated surface should not be allowed to dry prior to rinsing”.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.8.   Use description

Table 43

Use # 8 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

Diluted product is applied by spraying in an automated way

Spraying is only applied downwards and in a horizontal direction.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.8.1.   Use-specific instructions for use

See general directions for use.

4.8.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

4.8.3.   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.

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

See general directions for use.

4.8.5.   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.

4.9.   Use description

Table 44

Use # 9 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (closed room) (in absence of plants - for general hygiene purpose only)

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In agriculture/horticulture areas:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: By spraying.

Detailed description:

Diluted product is applied by spraying in an automated way without any operator being present

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.9.1.   Use-specific instructions for use

See general directions for use.

4.9.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

4.9.3.   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.

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

See general directions for use.

4.9.5.   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.

4.10.   Use description

Table 45

Use # 10 – Disinfection of animal housing via low-pressure spraying by user with personal enclosure

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

In animal housing:

Disinfection of hard/non-porous surfaces by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

Diluted product is automatically applied in all directions by low-pressure manual spraying via a spraying device.

The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)

Application rate(s) and frequency

Application Rate: Between 20 and 300 mL/m2

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.10.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.

4.10.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.10.3.   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.

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

See general directions for use.

4.10.5.   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.

4.11.   Use description

Table 46

Use # 11 – Disinfection of animal housing via low-pressure manual spraying by user without personal enclosure

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

In animal housing:

Disinfection of hard/non-porous surfaces by spraying with prior cleaning

Application method(s)

Method: Open system: spray treatment

Detailed description:

Diluted product is automatically applied in all directions by low-pressure automatic spraying via a spraying device.

Application rate(s) and frequency

Application Rate: Between 20 and 300 mL/m2

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.11.1.   Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.

4.11.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.11.3.   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.

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

See general directions for use.

4.11.5.   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.

4.12.   Use description

Table 47

Use # 12 – Disinfection of boots in footbaths in animal houses/husbandries

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

in animal housing/husbandries:

Disinfection of boots by dipping (not for walk-through) with prior cleaning.

Application method(s)

Method: Dipping

Detailed description:

Diluted product is put in the footbath

No rinse needed

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.12.1.   Use-specific instructions for use

See general directions for use.

4.12.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.12.3.   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.

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

See general directions for use.

4.12.5.   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.

4.13.   Use description

Table 48

Use # 13 – Disinfection of equipment by dipping

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning

Application method(s)

Method: Soaking.

Detailed description:

The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria, yeasts and viruses: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.13.1.   Use-specific instructions for use

See general directions for use.

4.13.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

4.13.3.   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.

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

See general directions for use.

4.13.5.   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.

4.14.   Use description

Table 49

Use # 14 – Disinfection in Aseptic Filling Lines (crown corks, cheese moulds and food crates) - Automated spraying closed systems

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food and beverage industry:

Disinfection of hard/non-porous surfaces by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

Diluted product is sprayed on the surfaces in an automated way without any user being present.

Application rate(s) and frequency

Application Rate: -

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.14.1.   Use-specific instructions for use

See general directions for use.

4.14.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

4.14.3.   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.

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

See general directions for use.

4.14.5.   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.

4.15.   Use description

Table 50

Use # 15 – Disinfection of equipment in the food and beverage industry by immersion

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food and beverage industry:

Disinfection of hard/non-porous surfaces/equipment (small parts such as equipment, spare parts, tools, valves, hoses, ..) by immersion in soaking baths with prior cleaning

Application method(s)

Method: Soaking.

Detailed description:

The concentrated product is pumped in a soaking bath and diluted to the desired use concentration, before immersion of items to be disinfected

Application rate(s) and frequency

Application Rate: -

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.15.1.   Use-specific instructions for use

See general directions for use.

4.15.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.15.3.   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.

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

See general directions for use.

4.15.5.   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.

4.16.   Use description

Table 51

Use # 16 – Disinfection of heat and ion exchangers, membrane filters and glass and PET bottles – CIP procedures

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food and beverage industry:

Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning

Application method(s)

Method: Closed system

Detailed description:

Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.

After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.

Application rate(s) and frequency

Application Rate: -

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.16.1.   Use-specific instructions for use

See general directions for use.

4.16.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Rinse the pump and disconnect it from the installation before maintenance”

4.16.3.   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.

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

See general directions for use.

4.16.5.   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.

4.17.   Use description

Table 52

Use # 17 – Disinfection of surfaces and equipment by low pressure spraying – spraying with personal enclosure

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device

The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device)

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.17.1.   Use-specific instructions for use

See general directions for use.

4.17.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.17.3.   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.

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

See general directions for use.

4.17.5.   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.

4.18.   Use description

Table 53

Use # 18 – Disinfection of surfaces and equipment by low pressure spraying – spraying without personal enclosure

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces/equipment by spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

Diluted product is automatically applied in all directions by low-pressure spraying via a spraying device.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.18.1.   Use-specific instructions for use

See general directions for use.

4.18.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.18.3.   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.

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

See general directions for use.

4.18.5.   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.

4.19.   Use description

Table 54

Use # 19 – Disinfection of surfaces and equipment by low pressure spraying, manually

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces/equipment by low-pressure spraying with prior cleaning

Application method(s)

Method: Manual application - spraying.

Detailed description:

Diluted product is manually applied by low-pressure spraying, only downwards and horizontal.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.19.1.   Use-specific instructions for use

See general directions for use.

4.19.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.19.3.   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.

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

See general directions for use.

4.19.5.   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.

4.20.   Use description

Table 55

Use # 20 – Disinfection of surfaces and equipment by low pressure spraying, automatically

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces/equipment by low-pressure spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

The diluted product is sprayed on the equipment

The user is present, seated in a personal enclosure/in a closed cabin (ex. tractor equipped with a spraying/foaming device).

Spraying is only applied downwards and in a horizontal direction.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.20.1.   Use-specific instructions for use

See general directions for use.

4.20.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

RPE are not mandatory during the application phase, on the condition that the user remains in the control room and do not enter the treated area.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.20.3.   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.

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

See general directions for use.

4.20.5.   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.

4.21.   Use description

Table 56

Use # 21 – Disinfection of surfaces and equipment by low pressure spraying – automatic spraying (closed room)

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces/equipment by low-pressure spraying with prior cleaning

Application method(s)

Method: Spraying

Detailed description:

The diluted solution is sprayed on the surfaces in an automated way without any user being present.

Application rate(s) and frequency

Application Rate: Between 20 and 200 mL/m2

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e.320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e.426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.21.1.   Use-specific instructions for use

See general directions for use.

4.21.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

RPE are not mandatory during the application phase, on the condition that the user remains in the control room and do not enter the treated area.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.21.3.   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.

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

See general directions for use.

4.21.5.   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.

4.22.   Use description

Table 57

Use # 22 – Disinfection of inner surfaces (pipelines, tanks, vessels, …) by CIP

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Bacterial spores

Development stage:

Common name: Viruses

Development stage:

Common name: Bacteriophages

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of hard/non-porous surfaces by CIP procedures (with circulation) with prior cleaning

Application method(s)

Method: Closed system

Detailed description:

Diluted product does automatically circulate from the CIP holding tanks through closed pipework and installations.

After the disinfection procedure, the vessels (pipework and tanks) are drained and rinsed with water under closed system conditions.

Application rate(s) and frequency

Application Rate: -

Dilution (%): - Against bacteria and yeasts: With 0,048 % PAA (Dilution of the product at 0.32 % i.e. 320 mL/100 L) in 15 min contact time, efficient use temperature from + 4 °C up to Room Temperature - Against bacteria (including bacterial spores) and yeasts: With 0,064 % PAA (Dilution of the product at 0.42 % i.e. 426.6 mL/100 L) in 60 min contact time, efficient use temperature from + 4 °C up to Room Temperature For additional activity against viruses (including bacteriophages): the product should be used at Room Temperature.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.22.1.   Use-specific instructions for use

See general directions for use.

4.22.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Rinse the pump and disconnect it from the installation before maintenance”

4.22.3.   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.

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

See general directions for use.

4.22.5.   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.

4.23.   Use description

Table 58

Use # 23 – Disinfection of water used for rinsing of recycled items during the washing process

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

.

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

In food industry:

Disinfection of water (in clean conditions) used for rinsing of recycled items = Water from drinking water quality shortly stored in tanks until use to rinse items such as bottles. The water should be disinfected to avoid recontamination and in an extent to avoid cross-contamination of inner bottle surfaces

Application method(s)

Method: Closed system

Detailed description:

Concentrated product will be pumped into a reservoir from which it is continuously dosed into the water stream.

Dilution of the product to the intended in-use concentration occurs in the water stream.

This application is a closed, automated process.

Application rate(s) and frequency

Application Rate: -

Dilution (%): Against bacteria and yeasts: With 0.008 % PAA (Dilution of the product at 0.0533 % i.e. 53.3 mL/100L) at Room Temperature in 15 min contact time.

Number and timing of application:

/

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

HDPE with screw and venting caps (weight depends on density of product):

Jerry cans (10 to 25 kg), Drums (200 to 250 kg), IBC (1 000 to 1 200 kg), 1 L bottles, bulk delivery.

4.23.1.   Use-specific instructions for use

See general directions for use.

4.23.2.   Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance”

4.23.3.   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.

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

See general directions for use.

4.23.5.   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

1.

All the surfaces to be disinfected must be cleaned before the disinfection procedure.

1.

Disinfection cycle:

Products must be diluted in potable water before use.

Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use.

Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use.

Only for use in areas that are inaccessible to the general public and companion animals.

No access for the general public during treatment.

Disinfection procedures by CIP: Final rinsing step (with potable water).

After the disinfection procedure, CIP vessels (pipework and tanks) are drained and rinsed with water under closed system conditions

Disinfection procedures by dipping: The bath is not intended to be re-used. Use the bath only once a day after work & replace it by a fresh solution daily.

Disinfection procedures by spraying: the surfaces to be disinfected must be wet enough in order to keep them wet during the required contact time for optimal disinfection. Then, the user should pay attention to wet surfaces completely with the disinfectant solution.

The Application Rate for spraying of diluted product must be between 20 and 30 mL/m2

5.2.   Risk mitigation measures

Dermal protection:

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

A protective coverall which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).

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

Indirect effects

The two products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion.

Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self-accelerated, exothermic decomposition and the formation of oxygen.

In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst.

First aid measures

Ø   General advice

Move out of dangerous area.

Take care of your own personal safety.

Take off immediately all contaminated clothing.

Ø   Inhalation

Take affected persons out into the fresh air.

Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.

If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately.

Ø   Skin contact

After contact with skin, wash immediately with plenty of water.

Consult a physician.

Take off immediately all contaminated clothing.

Immediately rinse contaminated or saturated clothing with water.

Ø   Eye contact

With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.

Protect unharmed eye.

Continue rinsing process with eye rinsing solution.

Call ambulance (caustic burn of the eyes)

Immediate further treatment in ophthalmic hospital/ophthalmologist.

Continue rinsing eye until arrival at ophthalmic hospital.

Ø   Ingestion

Do not induce vomiting.

Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation.

Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest.

Notify ambulance immediately (key word: acid burn).

Ø   Notes to physician

Therapy as for chemical burn.

Following inhalation:

Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area).

Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone).

If substance has been swallowed:

Aspiration hazard.

Risk of gaseous embolisms.

In case of excessive strain on the stomach due to gas evolution, insert siphon tube.

Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear.

If necessary, suck away leftover substance.

Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide.

Emergency measures to protect the environment

Observe regulations on prevention of water pollution (collect, dam up, cover up).

Do not allow to run into water channels, surface water or into the ground.

Ø   Methods for cleaning up

Clean contaminated surface thoroughly; recommended cleaning agent is water.

In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.

Ø   Additional advice

Make safe or remove all sources of ignition.

Isolate defective containers immediately, if possible and safe to do.

Shut off leak, if possible and safe to do.

Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal).

Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition).

Product taken out should not be returned into container.

Never return spilled product into its original container for re-use (risk of decomposition).

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

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place. Keep products away from direct sunlight, source of heat and ignition

The shelf life of the biocidal product is 6 months.

The products must be stored at Ambient Temperature.

6.   OTHER INFORMATION

Reference values of peracetic acid and hydrogen peroxide used for the risk assessment:

PAA: AECinhal = 0,5 mg/m3

HP: AECinhal = 1,25 mg/m3

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)

SOPUROXID 15

Market area: EU

 

HORTICLEAN 15 FORT

Market area: EU

AGRIOXID 15

Market area: EU

HyPro Biocide 15-22

Market area: EU

Authorisation number

EU-0026179-0005 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Peracetic acid

 

Active Substance

79-21-0

201-186-8

15,0

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

0,78

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

22,0

Acetic acid

 

Non-active substance

64-19-7

200-580-7

16,7

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

Trade name(s)

Oxypur CS

Market area: EU

Authorisation number

EU-0026179-0006 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Peracetic acid

 

Active Substance

79-21-0

201-186-8

15,0

Sulphuric acid

 

Non-active substance

7664-93-9

231-639-5

0,78

Hydrogen peroxide

 

Non-active substance

7722-84-1

231-765-0

22,0

Acetic acid

 

Non-active substance

64-19-7

200-580-7

16,7


(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.


22.6.2022   

EN

Official Journal of the European Union

L 166/118


COMMISSION IMPLEMENTING REGULATION (EU) 2022/965

of 21 June 2022

authorising the placing on the market of kernels from the edible variety of Jatropha curcas L. as a novel food and amending Implementing Regulation (EU) 2017/2470

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12(1) thereof,

Whereas:

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3)

On 29 August 2016, the company ‘JatroSolutions GmbH’ (‘the applicant’) submitted an application to the competent authority of Germany to place kernels from the edible variety of Jatropha curcas L., on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The applicant requested for hydrothermally treated whole and broken kernels from the edible variety of Jatropha curcas L. to be used as such (or candied or sugar preserved) or as processed nuts as snack, and as a food ingredient in cereal bars, in breakfast cereals, and in dried fruits.

(4)

Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients, and for which the final decision has not been taken before 1 January 2018 are to be treated as an application submitted under Regulation (EU) 2015/2283.

(5)

While the request for placing kernels from the edible variety of Jatropha curcas L. on the market as a novel food within the Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

(6)

On 1 March 2018, the applicant also made a request to the Commission for the protection of proprietary data on the management of the cultivation of the Jatropha curcas L. plant and the use of molecular markers (4), the compositional data including the nutritional information (5) and data on allergens (6), the information on biological and process contaminants (7), the analytical methods, including their validation, for the detection of phorbol esters in the Jatropha curcas L. kernels (8), the procedures for the verification of the phorbol ester content of the Jatropha curcas L. kernels (9), bacterial reverse mutation assays with the edible and non-edible Jatropha curcas L. defatted kernel meal and oil (10), and an in vitro mammalian cell micronucleus tests with the edible and non-edible Jatropha curcas L. defatted kernel meal and oil (11), submitted in support of the application.

(7)

On 19 October 2018, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of kernels from the edible variety of Jatropha curcas L. as a novel food.

(8)

On 24 November 2021, the Authority adopted its scientific opinion ‘Safety of hydrothermally treated kernels from edible Jatropha curcas L. (‘Chuta’) as a novel food pursuant to Regulation (EU) 2015/2283 (12) in accordance with Article 11 of Regulation (EU) 2015/2283.

(9)

In its scientific opinion, the Authority concluded that kernels from the edible variety of Jatropha curcas L. are safe under the proposed conditions of use. Therefore, that scientific opinion gives sufficient grounds to establish that novel food kernels from the edible variety of Jatropha curcas L., when used as such (or candied or sugar preserved) or as processed nuts as snack and as a food ingredient in cereal bars, in breakfast cereals, and in dried fruits, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(10)

In its scientific opinion, the Authority also concluded that consumption of this novel food may either induce primary sensitisation to kernels from the edible variety of Jatropha curcas L. that could lead to allergic reactions or could elicit allergic reactions to persons that are allergic to nuts. It came to such conclusion on the basis of the weight of the available evidence and considering the elevated (32 %) protein content of the kernels from the edible variety of Jatropha curcas L., and published information demonstrating the presence of a number of allergenic proteins in the kernels from the non-edible variety of Jatropha curcas L.. However, considering that at present there is no epidemiological evidence on allergic reactions to kernels from the edible variety of Jatropha curcas L. in the areas of Mexico where they are commonly consumed, and considering the negative cross reactivity results of proteins from the kernels from the edible variety of Jatropha curcas L. to proteins from some common nuts in in vitro enzyme-linked immunosorbent assays (‘ELISA’), and the negative polymerase chain reaction (‘PCR’) tests conducted with the kernels from the edible variety of Jatropha curcas L. for allergens of other nuts, the Commission considers that no specific labelling requirement as to its allergenicity should be included in the Union list of authorised novel foods.

(11)

In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the scientific data on the management of the cultivation of the Jatropha curcas L. plant and the use of molecular markers, the compositional data including the nutritional information and data on allergens, the information on biological and process contaminants, the analytical methods, including their validation, for the detection of phorbol esters in the Jatropha curcas L. kernels, the procedures for the verification of the phorbol ester content of the Jatropha curcas L. kernels, the bacterial reverse mutation assays with the edible and non-edible Jatropha curcas L. defatted kernel meal and oil, and the in vitro mammalian cell micronucleus tests with the edible and non-edible Jatropha curcas L. defatted kernel meal and oil, without which it could not have assessed the novel food and reached its conclusion.

(12)

The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those studies and tests and to clarify its claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.

(13)

The applicant declared that they held proprietary and exclusive rights of reference to the scientific data from the management of the cultivation of the Jatropha curcas L. plant and the use of molecular markers, the compositional data including the nutritional information and data on allergens, the information on biological and process contaminants, the analytical methods, including their validation, for the detection of phorbol esters in the Jatropha curcas L. kernels, the sampling procedures for the verification of the phorbol ester content of the Jatropha curcas L. kernels, the bacterial reverse mutation assays with the edible and non-edible Jatropha curcas L. defatted kernel meal and oil, and the in vitro mammalian cell micronucleus tests with the edible and non-edible Jatropha curcas L. defatted kernel meal and oil, at the time they submitted the application and therefore third parties could not lawfully access, use or refer to those data.

(14)

The Commission assessed all the information provided by the applicant and considered that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the scientific data on the management of the cultivation of the Jatropha curcas L. plant and the use of molecular markers, the compositional data including the nutritional information and data on allergens, the information on biological and process contaminants, the analytical methods, including their validation, for the detection of phorbol esters in the Jatropha curcas L. kernels, the procedures for the verification of the phorbol ester content of the Jatropha curcas L. kernels, the bacterial reverse mutation assays with the edible and non-edible Jatropha curcas L. defatted kernel meal and oil, and the in vitro mammalian cell micronucleus tests with the edible and non-edible Jatropha curcas L. defatted kernel meal and oil, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place kernels from Jatropha curcas L. on the market within the Union during a period of 5 years from the entry into force of this Regulation.

(15)

However, restricting the authorisation of kernels from the edible variety of Jatropha curcas L. and the reference to the scientific data contained in the applicant’s file for the sole use by them does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.

(16)

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

1.   Kernels from the edible variety of Jatropha curcas L. are authorised to be placed on the market within the Union.

Kernels from the edible variety of Jatropha curcas L. shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company ‘JatroSolutions GmbH’ (13) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 12 July 2022, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of ‘JatroSolutions GmbH’.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from 12 July 2022 without the agreement of ‘JatroSolutions GmbH’.

Article 4

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

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

Done at Brussels, 21 June 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 327, 11.12.2015, p. 1.

(2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

(3)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

(4)  JatroSolutions GmbH (2018 and 2019, unpublished)

(5)  JatroSolutions GmbH (2021, unpublished)

(6)  JatroSolutions GmbH (2020 and 2021, unpublished)

(7)  JatroSolutions GmbH (2021, unpublished)

(8)  JatroSolutions GmbH (2021, unpublished)

(9)  JatroSolutions GmbH (2021, unpublished)

(10)  JatroSolutions GmbH (2021, unpublished)

(11)  JatroSolutions GmbH (2021, unpublished)

(12)  EFSA Journal 2022; 20(1):6998.

(13)  Address: Echterdinger Strasse 30, 70599 Stuttgart, Germany.


ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data Protection

Jatropha curcas L. (edible variety) kernels

Specified food category

Maximum levels (g/100g)

The designation of the novel food on the labelling of the foodstuffs containing it shall be “kernels from edible Jatropha curcas L.”

 

Authorised on 12 July 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: “JatroSolutions GmbH”, Echterdinger Strasse 30, 70599 Stuttgart, Germany. During the period of data protection, the novel food kernels from the edible variety of Jatropha curcas L. is authorised for placing on the market within the Union only by “JatroSolutions GmbH”, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of “JatroSolutions GmbH”.

End date of the data protection: 12 July 2027.’

Kernels as such, candied or sugar preserved and as processed nuts

 

Cereal bars

5

Breakfast cereals

5

Dried fruits

5

 

(2)

in Table 2 (Specifications), the following entry is inserted in alphabetical order:

Authorised Novel Food

Specification

Jatropha curcas L. (edible variety) kernels

Description:

The kernels are obtained from the seeds of the ripe fruits of the edible variety of the Jatropha curcas L. plants that produce kernels with non-detectable levels of phorbol esters, following a series of steps involving the cleaning and de-husking of the fruits to obtain the seeds, the drying of the seeds, the cleaning of the seeds to remove debris and other residues, mechanical deshelling of the seeds to obtain the kernels, and the hydrothermal treatment (> 120 °C for 40 minutes) of the kernels to reduce anti-nutrients and the microbiological load.

As the edible variety of the Jatropha curcas L. plants, producing kernels that contain non-detectable levels of phorbol esters, are phenotypically undistinguishable from the non-edible variety, only the appropriate edible variety of Jatropha curcas L. plants should be used in the production of the novel food. The entire production process must ensure that the mixing of edible and non-edible kernels does not occur.

The absence of mixing of edible with non-edible kernels shall be confirmed by analytical controls for phorbol esters carried on each batch of the seeds after the seed-drying step and before the deshelling step according to the sampling procedure of Table A. Five laboratory samples extracted from each aggregate sample are de-shelled, ground, and analysed for phorbol esters using a validated UHPLC-UV-MS(b) method. Only the batches in which phorbol esters are undetectable in all five samples are further processed to the seed deshelling and kernel hydrothermal treatment steps.

Table A

Batch weight (tons)

Weight or number of sublots

Number of incremental samples

≥ 500

100 tons

100

> 100 and < 500

5 sub-lots

100

> 10 and ≤ 100

5 sub-lots

100

> 5,0 and ≤ 10

-

80

> 1 and ≤ 5,0

-

60

> 0,1 and ≤ 1,0

-

30

≤ 0,1

-

10

Each sub-lot shall be sampled separately. Aggregate samples are composed by a minimum of 10 incremental samples. The minimum amount of an aggregate sample shall be 3,5 kg. This amount may increase proportionally according to the number of incremental samples taken.

Characteristics/Composition:

 

Moisture: ≤ 3,0 %

 

Total fat: 54,0 – 61,0 %

 

Total protein: 21,0 – 32,0 %

 

Total fibre: 6,0 – 10,0 %

 

Ash: 3,0 – 5,0 %

Contaminants:

 

Phorbol esters (μg TPA eq(a)/g kernel)(b): ≤ 0,75 (LOD)(c)

 

Lead: ≤ 0,20 mg/kg

 

Cadmium: ≤ 0,20 mg/kg

 

Sum of aflatoxins B1, B2, G1, G2: ≤ 4,0 μg/kg

 

Microbiological criteria:

 

Total aerobic microbial count: ≤ 1 000 CFU/g

 

Total yeast/moulds count: ≤ 100 CFU/g

 

Enterobacteriaceae: ≤ 10 CFU/g

 

Salmonella sp.: Absent in 25 g

 

Listeria monocytogenes: ≤ 100 CFU/g

(a) TPAeq: 12-O-tetradecanoylphorbol-13-acetate equivalent; (b)Validated Ultra-High-Performance Liquid Chromatography coupled to Ultraviolet Spectrophotometry and Mass Spectrometry (UHPLC-UV-MS) method for detection of phorbol ester peaks; (c) Limit of Detection (Only batches with concentrations of PEs below the LOD can be fully processed.); CFU: Colony Forming Units’


22.6.2022   

EN

Official Journal of the European Union

L 166/125


COMMISSION IMPLEMENTING REGULATION (EU) 2022/966

of 21 June 2022

amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use, the specific labelling requirements and specifications of the novel food Calanus finmarchicus oil

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3)

The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes Calanus finmarchicus oil as an authorised novel food.

(4)

Commission Implementing Decision (EU) 2017/2353 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market of Calanus finmarchicus oil as a novel food ingredient to be used in food supplements intended for the general population.

(5)

On 30 November 2021, the company ‘Calanus A/S’ (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the specifications, of the conditions of use, and of the specific labelling requirements of the novel food ‘Calanus finmarchicus oil’. The applicant proposed to change the specifications of Calanus finmarchicus oil with regard to astaxanthin esters to the level up to 0,25 %. They requested an increased maximum level of up to 0,25 % of astaxanthin esters contained in Calanus finmarchicus oil for persons older than fourteen years of age, in addition to the currently authorised maximum level of < 0,1 % of astaxanthin esters in Calanus finmarchicus oil for the general population. For food supplements containing the currently authorised level of < 0,1 % astaxanthin esters that are intended for the general population, the applicant proposed reducing the currently authorised use levels of the Calanus finmarchicus oil from 2,3 g/day to 1,0 g/day and excluding infants and young children.

(6)

As a consequence of the proposed changes in the specifications Calanus finmarchicus oil and the conditions of use of this novel food, the applicant proposed an amendment in its labelling to ensure that consumers only use the food supplements intended for their age group. In addition, in light of the current use of food supplements containing astaxanthin esters in the Union market, the applicant also proposed additional specific labelling to warn consumers not to use Calanus finmarchicus oil food supplements, when other food supplements containing astaxanthin esters are consumed on the same day.

(7)

The Commission considers that the requested update of the Union list concerning specifications of Calanus finmarchicus oil and the resulting changes in its conditions of use for the population groups older than 14 years of age is not liable to have an effect on human health and that a safety evaluation by the European Food Safety Authority (‘the Authority’) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The increase in the astaxanthin esters in oil from Calanus finmarchicus from < 0,1 % to ≤ 0,25 % in food supplements intended for population groups older than 14 years is expected to result in intakes of astaxanthin esters which, in combination with the intake of astaxanthin from the normal diet, are not expected to exceed the revised Acceptable Daily Intake (‘ADI’) of 0,2 mg astaxanthin/kg bw, established by the Authority (5).

(8)

Furthermore, the Commission considers that the requested update of the Union list concerning the reduction of the currently authorised use levels of Calanus finmarchicus oil from 2,3 g/day to 1,0 g/day in food supplements intended for the general population that contain < 0,1 % astaxanthin esters, and the exclusion of infants and young children is also not liable to have an effect on human health and that a safety evaluation by the Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The exclusion of infants and young children is justified because the anticipated combined intake of astaxanthin esters from food supplements containing Calanus finmarchicus oil with levels of < 0,1 % astaxanthin esters and from the normal diet is expected to exceed the revised Acceptable Daily Intake (‘ADI’) of 0,2 mg astaxanthin/kg of body weight established by the Authority for these groups of consumers.

(9)

The proposed change to the specifications and conditions of use of Calanus finmarchicus oil as regards the astaxanthin esters values are in line with the conclusions of the safety assessment conducted by the Authority on astaxanthin. Therefore, it is appropriate to amend the specifications and the conditions of use of the novel food Calanus finmarchicus oil at the proposed astaxanthin esters levels.

(10)

The proposed changes to the labelling requirements of Calanus finmarchicus oil are in line with the conclusions of the safety assessment conducted by the Authority on astaxanthin. In addition, the Commission considers appropriate to lay down additional labelling requirement in order to prevent concomitant consumption of astaxanthin food supplements, which is likely to exceed the ADI established by the Authority. Therefore, it is appropriate to include additional labelling requirements for that novel food.

(11)

The information provided in the application gives sufficient grounds to establish that the changes to the conditions of use, the specific labelling requirements and specifications of the novel food Calanus finmarchicus oil are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

(12)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(13)

In order to provide business operators with sufficient time to adjust their practices to comply with the requirements of this Regulation, transitional measures should be laid down as regards food supplements containing Calanus finmarchicus oil, which have been lawfully placed on the Union market or dispatched from third countries for the Union, before the date of entry into force of this Regulation.

(14)

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

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

1.   Calanus finmarchicus oil food supplements which were lawfully placed on the market before the date of entry into force of this Regulation, may be marketed until their date of minimum durability or use by date.

2.   Calanus finmarchicus oil food supplements which were dispatched from a third country and were on their way to the Union before the date of entry into force of this Regulation and complying with the rules in force before the date of entry into force of this Regulation, may be marketed until their date of minimum durability or use by date.

Article 3

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

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

Done at Brussels, 21 June 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 327, 11.12.2015, p. 1.

(2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

(3)  Commission Implementing Decision (EU) 2017/2353 of 14 December 2017 authorising the placing on the market of oil from Calanus finmarchicus as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 336, 16.12.2017, p. 45).

(4)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

(5)  Safety of astaxanthin for its use as a novel food in food supplements; EFSA Journal 2020;18(2):5993.


ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the entry for ‘Calanus finmarchicus oil’ is replaced by the following:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Calanus finmarchicus oil

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘oil from Calanus finmarchicus (crustacean)’.

2.

The labelling of food supplements containing Calanus finmarchicus oil shall bear a statement that those food supplements should not be consumed:

a)

if other food supplements containing astaxanthin esters are consumed on the same day.

b)

by infants and children younger than 3 years.

c)

by children younger than 14 years, if the ingredient contains ≥ 0,1 % astaxanthin.’

 

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

1,0 g/day (< 0,1 % astaxanthin esters, resulting in < 1,0 mg astaxanthin per day) for the general population, excluding infants and young children

2,3 g/day (from 0,1 % to ≤ 0,25 % astaxanthin esters, resulting in ≤ 5,75 mg astaxanthin per day) for the general population older than 14 years of age

(2)

in Table 2 (Specifications), the entry for ‘Calanus finmarchicus oil’ is replaced by the following:

Authorised Novel Food

Specifications

Calanus finmarchicus oil

Description/Definition:

The novel food is ruby coloured, slightly viscous oil with a slight shellfish odour extracted from the crustacean (marine zooplankton) Calanus finmarchicus. The ingredient consists primarily of wax esters (> 85 %) with minor amounts of triglycerides and other neutral lipids.

Specifications:

Water: < 1,0 %

Wax esters: > 85 %

Total fatty acids: > 46 %

Eicosapentaenoic acid (EPA): > 3,0 %

Docosahexaenoic acid (DHA): > 4,0 %

Total fatty alcohols: > 28 %

C20:1 n-9 fatty alcohol: > 9,0 %

C22:1 n-11 fatty alcohol: > 12 %

Trans fatty acids: < 1,0 %

Astaxanthin esters: ≤ 0,25 %

Peroxide value (PV): < 3,0 meq. O2/kg’


DECISIONS

22.6.2022   

EN

Official Journal of the European Union

L 166/130


COUNCIL DECISION (EU) 2022/967

of 13 June 2022

on the position to be taken on behalf of the European Union within the Association Council established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part, as regards the adoption of the EU-Republic of Moldova Association Agenda

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 217 in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1)

The Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (1) (‘the Agreement’) was signed on 27 June 2014 and entered into force on 1 July 2016.

(2)

Pursuant to Article 436(1) of the Agreement, the Association Council has the power to adopt recommendations, for the purposes of attaining the objectives of the Agreement.

(3)

To facilitate the application of the Agreement, the Parties have agreed to establish an association agenda with a view to providing a list of priorities for their joint work on a sector-by-sector basis.

(4)

The Association Council is to adopt the recommendation on the EU-Republic of Moldova Association Agenda for 2021-2027 by written procedure.

(5)

It is appropriate to establish the position to be taken on the Union’s behalf in the Association Council, as the EU-Republic of Moldova Association Agenda for 2021-2027 will be the basis for programming under the Neighbourhood, Development and International Cooperation Instrument.

(6)

The position of the Union within the Association Council on the adoption of the EU-Republic of Moldova Association Agenda for 2021-2027 should therefore be based on the draft recommendation of the Association Council,

HAS ADOPTED THIS DECISION:

Article 1

The position to be taken on the Union’s behalf within the Association Council established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part, as regards the adoption of the EU-Republic of Moldova Association Agenda for 2021-2027 shall be based on the draft recommendation of the Association Council attached to this Decision.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 13 June 2022.

For the Council

The President

M. FESNEAU


(1)  OJ L 260, 30.8.2014, p. 4.


DRAFT

RECOMMENDATION No ../2022 OF THE EU-REPUBLIC OF MOLDOVA ASSOCIATION COUNCIL

of …

on the EU-Republic of Moldova Association Agenda

THE EU-REPUBLIC OF MOLDOVA ASSOCIATION COUNCIL,

Having regard to the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part,

Whereas:

(1)

The Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (1) (‘the Agreement’) was signed on 27 June 2014 and entered into force on 1 July 2016.

(2)

In accordance with Article 436(1) of the Agreement, the Association Council has the power to adopt recommendations, for the purposes of attaining the objectives of the Agreement.

(3)

Pursuant to Article 453(1) of the Agreement, the Parties are to take any general or specific measures required to fulfil their obligations under the Agreement and are to ensure that the objectives set out in the Agreement are attained.

(4)

Article 11 of the Rules of Procedure of the Association Council provides for the possibility of taking decisions by written procedure between sessions if both Parties so agree.

(5)

The Union and the Republic of Moldova have agreed to consolidate their partnership by agreeing on a set of priorities for the period 2021–2027 for the joint work towards achieving the objectives of political association and economic integration as set out in the Agreement.

(6)

The Parties to the Agreement have agreed on the text of the EU-Republic of Moldova Association Agenda for 2021–2027, which will support the implementation of the Agreement, focusing cooperation on commonly identified shared interests,

HAS ADOPTED THE FOLLOWING RECOMMENDATION:

Article 1

The Association Council recommends that the Parties implement the EU-Republic of Moldova Association Agenda, as set out in the Annex (*1).

Article 2

The EU-Republic of Moldova Association Agenda, as set out in the Annex, shall replace the EU-Republic of Moldova Association Agenda which was adopted on 19 August 2017.

Article 3

This Recommendation shall take effect on the date of its adoption.

Done at …,

For the Association Council

The Chair


(1)  OJ EU L 260, 30.8.2014, p. 4.

(*1)  See document ST 6701/22 ADD 2 at https://register.consilium.europa.eu.


22.6.2022   

EN

Official Journal of the European Union

L 166/134


COUNCIL DECISION (EU) 2022/968

of 16 June 2022

appointing two members of the Court of Auditors

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 286(2) thereof,

Having regard to the proposals by the Republic of Cyprus and Malta,

Having regard to the opinions of the European Parliament (1),

Whereas:

(1)

The term of office of Mr Leo BRINCAT is due to expire on 30 September 2022.

(2)

The term of office of Mr Lazaros LAZAROU is due to expire on 1 November 2022.

(3)

Two members should therefore be appointed to the Court of Auditors,

HAS ADOPTED THIS DECISION:

Article 1

The following are hereby appointed members of the Court of Auditors:

Mr Lefteris CHRISTOFOROU, for the period from 2 November 2022 to 1 November 2028,

Mr George Marius HYZLER, for the period from 1 October 2022 to 30 September 2028.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 16 June 2022.

For the Council

The President

O. DUSSOPT


(1)  Opinions of 3 May 2022 (not yet published in the Official Journal).


22.6.2022   

EN

Official Journal of the European Union

L 166/135


COUNCIL DECISION (EU) 2022/969

of 16 June 2022

on the position to be taken on behalf of the European Union in the World Forum for Harmonization of Vehicle Regulations of the United Nations Economic Commission for Europe as regards the proposals for modifications to UN Regulations Nos 12, 13, 13-H, 22, 24, 48, 49, 51, 53, 54, 74, 79, 85, 86, 90, 100, 106, 109, 117, 127, 129, 131, 135, 136, 137, 141, 145, 148, 149, 150, 157 and 162, as regards the proposal for modifications to UN GTR No 2, as regards the proposal for a new UN Regulation on reverse warning, as regards the proposal for a new UN Global Technical Regulation on durability of pollution control devices for two- and three-wheelers, as regards the proposal for a new Consolidated Resolution concerning exhaust ultra-fine particle numbers measurement for heavy duty vehicles, and as regards the proposal for authorisation to develop Amendment 4 to UN GTR No 3

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114, in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1)

By Council Decision 97/836/EC (1), the Union acceded to the Agreement of the United Nations Economic Commission for Europe (UNECE) concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions (‘Revised 1958 Agreement’). The Revised 1958 Agreement entered into force on 24 March 1998.

(2)

By Council Decision 2000/125/EC (2), the Union acceded to the Agreement concerning the establishing of global technical regulations for wheeled vehicles, equipment and parts which can be fitted and/or be used on wheeled vehicles (‘Parallel Agreement’). The Parallel Agreement entered into force on 15 February 2000.

(3)

Regulation (EU) 2018/858 of the European Parliament and of the Council (3) lays down administrative provisions and technical requirements for type approval and placing on the market of all new vehicles, systems, components and separate technical units. This Regulation incorporates regulations adopted under the Revised 1958 Agreement (‘UN Regulations’) in the EU type approval system, either as requirements for type approval or as alternatives to Union legislation.

(4)

Pursuant to Article 1 of the Revised 1958 Agreement and Article 6 of the Parallel Agreement, the UNECE World Forum for Harmonization of Vehicle Regulations (‘UNECE WP.29’) may adopt proposals for modifications to UN Regulations, UN Global Technical Regulations (‘UN GTRs’) and UN Resolutions, as well as proposals for new UN Regulations, UN GTRs and UN Resolutions concerning the approval of vehicles. Moreover, pursuant to those provisions, UNECE WP.29 may adopt proposals for authorisations to develop amendments to UN GTRs or to develop new UN GTRs and may adopt proposals for the extension of mandates for UN GTRs.

(5)

At the 187th session of the World Forum to be held between 21 and 24 June 2022, UNECE WP.29 intends to adopt the proposals for modifications to UN Regulations Nos 12, 13, 13-H, 22, 24, 48, 49, 51, 53, 54, 74, 79, 85, 86, 90, 100, 106, 109, 117, 127, 129, 131, 135, 136, 137, 141, 145, 148, 149, 150, 157 and 162; the proposal for modifications to UN GTR No 2; the proposal for a new UN Regulation on reverse warning; the proposal for a new UN GTR on durability of pollution control devices for two- and three-wheelers; and the proposal for a new Consolidated Resolution concerning exhaust ultra-fine particle numbers measurement for heavy duty vehicles. Moreover, UNECE WP.29 intends to adopt the proposal for authorisation to develop Amendment 4 to UN GTR No 3 on motorcycle braking.

(6)

It is appropriate to establish the position to be taken on the Union’s behalf in UNECE WP.29, as regards the adoption of those proposals, as the UN Regulations will be binding on the Union and, together with the UN GTRs and UN Resolutions, capable of decisively influencing the content of Union law in the field of vehicle type approval.

(7)

In the light of experience and technical developments, the requirements relating to certain elements or features covered by UN Regulations Nos 12, 13, 13-H, 22, 24, 48, 49, 51, 53, 54, 74, 79, 85, 86, 90, 100, 106, 109, 117, 127, 129, 131, 135, 136, 137, 141, 145, 148, 149, 150, 157, 162 and UN GTR No 2 need to be amended or supplemented.

(8)

In order to allow for technical progress and in order to improve vehicle safety and reduce environmental footprint, a new UN Regulation on reverse warning, a new UN GTR on durability of pollution control devices for two- and three-wheelers and a new Consolidated Resolution concerning exhaust ultra-fine particle numbers measurement for heavy duty vehicles need to be adopted,

HAS ADOPTED THIS DECISION:

Article 1

The position to be taken on behalf of the European Union in the 187th session of the UNECE World Forum for Harmonization of Vehicle Regulations to be held between 21 and 24 June 2022 shall be to vote in favour of the proposals listed in the Annex to this Decision.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 16 June 2022.

For the Council

The President

O. DUSSOPT


(1)  Council Decision 97/836/EC of 27 November 1997 with a view to accession by the European Community to the Agreement of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions (‘Revised 1958 Agreement’) (OJ L 346, 17.12.1997, p. 78).

(2)  Council Decision 2000/125/EC of 31 January 2000 concerning the conclusion of the Agreement concerning the establishing of global technical regulations for wheeled vehicles, equipment and parts which can be fitted and/or be used on wheeled vehicles (‘Parallel Agreement’) (OJ L 35, 10.2.2000, p. 12).

(3)  Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).


ANNEX

Regulation No

Agenda item title

Document reference (1)

12

Proposal for the 05 series of amendments to UN Regulation No 12 (Steering mechanism)

ECE/TRANS/WP.29/GRSP/70, para. 8, based on ECE/TRANS/WP.29/GRSP/2021/18, as amended by Annex II to the report

ECE/TRANS/WP.29/2022/69

13

Proposal for a Supplement 19 to the 11 series of amendments to UN Regulation No 13 (Heavy vehicle braking)

ECE/TRANS/WP.29/GRVA/12, para. 82, based on ECE/TRANS/WP.29/GRVA/2022/9

ECE/TRANS/WP.29/2022/77

13

Proposal for a Supplement 1 to the 12 series of amendments to UN Regulation No 13 (Heavy vehicle braking)

ECE/TRANS/WP.29/GRVA/12, para. 82, based on ECE/TRANS/WP.29/GRVA/2022/9

ECE/TRANS/WP.29/2022/78

13-H

Proposal for a Supplement 4 to UN Regulation No 13-H (Braking of light vehicles)

ECE/TRANS/WP.29/GRVA/12, para. 83, based on ECE/TRANS/WP.29/GRVA/2022/10, as amended by GRVA-12-24

ECE/TRANS/WP.29/2022/79

22

Proposal for Supplement 2 to the 06 series of amendments to UN Regulation No 22 (Protective helmets)

ECE/TRANS/WP.29/GRSP/70, para. 16, based on ECE/TRANS/WP.29/GRSP/2021/24 as amended by Annex III to the report

ECE/TRANS/WP.29/2022/63

24

Proposal for Supplement 8 to the 03 series of amendments to UN Regulation No 24 (Visible pollutants, measurement of power of C.I. engines (Diesel smoke))

ECE/TRANS/WP.29/GRPE/85, para. 35, based on ECE/TRANS/WP.29/GRPE/2022/4

ECE/TRANS/WP.29/2022/73

48

Proposal for Supplement 16 to the 06 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)

ECE/TRANS/WP.29/GRE/85, paras. 17, 31 and 33, based on ECE/TRANS/WP.29/GRE/2021/16 as amended by GRE-85-23, ECE/TRANS/WP.29/GRE/2021/18 as amended by GRE-85-33 and ECE/TRANS/WP.29/GRE/2020/5/Rev.2 as amended by GRE-85-26

ECE/TRANS/WP.29/2022/89

48

Proposal for Supplement 3 to the 07 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)

ECE/TRANS/WP.29/GRE/85, para. 17, 31 and 33, based on ECE/TRANS/WP.29/GRE/2021/16 as amended by GRE-85-23, ECE/TRANS/WP.29/GRE/2021/18 as amended by GRE-85-33 and ECE/TRANS/WP.29/GRE/2020/5/Rev.2, as amended by GRE-85-26

ECE/TRANS/WP.29/2022/90

48

Proposal for Supplement 1 to the 08 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)

ECE/TRANS/WP.29/GRE/85, para. 17, 31 and 33, based on ECE/TRANS/WP.29/GRE/2021/16 as amended by GRE-85-23, ECE/TRANS/WP.29/GRE/2021/18 as amended by GRE-85-33 and ECE/TRANS/WP.29/GRE/2020/5/Rev.2 as amended by GRE-85-26

ECE/TRANS/WP.29/2022/91

48

Proposal for Supplement 8 to the 03 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)

ECE/TRANS/WP.29/GRE/85, para. 20, based on ECE/TRANS/WP.29/GRE/2021/17, as amended by GRE-85-12 and para. 19 of the report

ECE/TRANS/WP.29/2022/95

48

Proposal for Supplement 21 to the 04 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)

ECE/TRANS/WP.29/GRE/85, para. 20, based on ECE/TRANS/WP.29/GRE/2021/17, as amended by GRE-85-12 and para. 19 of the report

ECE/TRANS/WP.29/2022/96

48

Proposal for Supplement 16 to the 05 series of amendments to UN Regulation No 48 (Installation of lighting and light-signalling devices)

ECE/TRANS/WP.29/GRE/85, para. 20, based on ECE/TRANS/WP.29/GRE/2021/17, as amended by GRE-85-12 and para. 19 of the report

ECE/TRANS/WP.29/2022/97

49

Proposal for Supplement 1 to the 07 series of amendments to UN Regulation No 49 (Emissions of compression ignition and positive ignition (LPG and CNG) engines)

ECE/TRANS/WP.29/GRPE/85, para. 29, based on ECE/TRANS/WP.29/GRPE/2022/3 and GRPE-85-47 as amended by Annex IV

ECE/TRANS/WP.29/2022/74

51

Proposal for Supplement 7 to 03 series of amendments to UN Regulation No 51 (Noise of M and N categories of vehicles)

ECE/TRANS/WP.29/GRBP/72 and ECE/TRANS/WP.29/GRBP/73, based on ECE/TRANS/WP.29/GRBP/2021/22 as amended by para. 5 of ECE/TRANS/WP.29/GRBP/72, ECE/TRANS/WP.29/GRBP/2022/4 as amended by GRBP-75-37, ECE/TRANS/WP.29/GRBP/2022/3 as amended by GRBP-75-36 and para. 4 of ECE/TRANS/WP.29/GRBP/73, ECE/TRANS/WP.29/GRBP/2022/8 as amended by para. 6 of ECE/TRANS/WP.29/GRBP/73, GRBP-74-40 as amended by para. 9 of ECE/TRANS/WP.29/GRBP/73

ECE/TRANS/WP.29/2022/84,

WP.29-187-07

53

Proposal for Supplement 23 to the 01 series of amendments to UN Regulation No 53 (Installation of lighting and light-signalling devices for L3 vehicles)

ECE/TRANS/WP.29/GRE/85, para. 23, and ECE/TRANS/WP.29/GRE/83, para. 36, based on ECE/TRANS/WP.29/GRE/2021/19 and ECE/TRANS/WP.29/GRE/2020/13/Rev.1 as amended by GRE-83-51

ECE/TRANS/WP.29/2022/98

53

Proposal for Supplement 6 to the 02 series of amendments to UN Regulation No 53 (Installation of lighting and light-signalling devices for L3 vehicles)

ECE/TRANS/WP.29/GRE/85, para. 24, and ECE/TRANS/WP.29/GRE/83, para. 36, based on ECE/TRANS/WP.29/GRE/2021/20 and ECE/TRANS/WP.29/GRE/2020/13/Rev.1 as amended by GRE-83-51

ECE/TRANS/WP.29/2022/99

53

Proposal for Supplement 3 to the 03 series of amendments to UN Regulation No 53 (Installation of lighting and light-signalling devices for L3 vehicles)

ECE/TRANS/WP.29/GRE/85, para. 24, and ECE/TRANS/WP.29/GRE/83, para. 36, based on ECE/TRANS/WP.29/GRE/2021/20 and ECE/TRANS/WP.29/GRE/2020/13/Rev.1 as amended by GRE-83-51

ECE/TRANS/WP.29/2022/100

54

Proposal for Supplement 25 to the original series of amendments to UN Regulation No 54 (Tyres for commercial vehicles and their trailers)

ECE/TRANS/WP.29/GRBP/73, based on ECE/TRANS/WP.29/GRBP/2022/6 and ECE/TRANS/WP.29/GRBP/2021/13, as amended by GRBP-75-31-Rev.2

ECE/TRANS/WP.29/2022/85

74

Proposal for Supplement 14 to the 01 series of amendments to UN Regulation No 74 (Installation of lighting and light-signalling devices for mopeds)

ECE/TRANS/WP.29/GRE/85, para. 25, based on ECE/TRANS/WP.29/GRE/2021/21

ECE/TRANS/WP.29/2022/101

74

Proposal for Supplement 2 to the 02 series of amendments to UN Regulation No 74 (Installation of lighting and light-signalling devices for mopeds)

ECE/TRANS/WP.29/GRE/85, para. 25, based on ECE/TRANS/WP.29/GRE/2021/21

ECE/TRANS/WP.29/2022/102

79

Proposal for a Supplement 8 to the 03 series of amendments to UN Regulation No 79 (Steering Equipment)

ECE/TRANS/WP.29/GRVA/12, para. 65-66, based on ECE/TRANS/WP.29/GRVA/2022/6, as amended by GRVA-12-43 and ECE/TRANS/WP.29/GRVA/2021/11, as amended by GRVA-12-19

ECE/TRANS/WP.29/2022/80

79

Proposal for a Supplement 3 to the 04 series of amendments to UN Regulation No 79 (Steering Equipment)

ECE/TRANS/WP.29/GRVA/12, para. 65-66, based on ECE/TRANS/WP.29/GRVA/2022/6, as amended by GRVA-12-43 and ECE/TRANS/WP.29/GRVA/2021/11, as amended by GRVA-12-19

ECE/TRANS/WP.29/2022/81

85

Proposal for Supplement 11 to UN Regulation No 85 (Measurement of the net power and the 30 min. power)

ECE/TRANS/WP.29/GRPE/85, para. 37, based on ECE/TRANS/WP.29/GRPE/2022/5 as amended by GRPE-85-11 and during the session as reproduced in Annex V

ECE/TRANS/WP.29/2022/75

86

Proposal for Supplement 4 to the 01 series of amendments to UN Regulation No 86 (Installation of lighting and light-signalling devices for agricultural vehicles)

ECE/TRANS/WP.29/GRE/85, para. 26, based on ECE/TRANS/WP.29/GRE/2021/22

ECE/TRANS/WP.29/2022/103

86

Proposal for Supplement 1 to the 02 series of amendments to UN Regulation No 86 (Installation of lighting and light-signalling devices for agricultural vehicles)

ECE/TRANS/WP.29/GRE/85, para. 26, based on ECE/TRANS/WP.29/GRE/2021/22

ECE/TRANS/WP.29/2022/104

90

Proposal for a Supplement 9 to the 02 series of amendments to UN Regulation No 90 (Replacement braking parts)

ECE/TRANS/WP.29/GRVA/12, para. 90, based on ECE/TRANS/WP.29/GRVA/2021/29, as amended by GRVA-12-16

ECE/TRANS/WP.29/2022/82

100

Proposal for Supplement 2 to the 03 series to UN Regulation No 100 (Electric power trained vehicles)

ECE/TRANS/WP.29/GRSP/70, para. 17, based on GRSP-70-26 as reproduced by Annex IV to the report

ECE/TRANS/WP.29/2022/64

106

Proposal for Supplement 20 to the original series of amendments to UN Regulation No 106 (Tyres for agricultural vehicles and their trailers)

ECE/TRANS/WP.29/GRBP/73, based on ECE/TRANS/WP.29/GRBP/2022/7

ECE/TRANS/WP.29/2022/86

109

Proposal for Supplement 11 to UN Regulation No 109 (Retreaded tyres for commercial vehicles and their trailers) Revision 1

ECE/TRANS/WP.29/GRBP/72, paras. 18 and 19, based on ECE/TRANS/WP.29/GRBP/2021/18 and ECE/TRANS/WP.29/GRBP/2021/16 as amended by Annex IV to the report and informal document WP.29-186-07

ECE/TRANS/WP.29/2022/7/Rev.1

117

Proposal for a new 03 series of amendments to UN Regulation No 117 (Tyre rolling resistance, rolling noise and wet grip)

ECE/TRANS/WP.29/GRBP/72, para. 23 and ECE/TRANS/WP.29/GRBP/73, based on GRBP-74-33-Rev.1, ECE/TRANS/WP.29/GRBP/2021/17 as amended by GRBP-74-31-Rev.1 and GRBP-75- 25-Rev.1

ECE/TRANS/WP.29/2022/83

127

Proposal for the 03 series of amendments to UN Regulation No 127 (Pedestrian safety)

ECE/TRANS/WP.29/GRSP/70, para. 18, based on ECE/TRANS/WP.29/GRSP/2021/28 as amended by Annex V to the report

ECE/TRANS/WP.29/2022/70

129

Proposal for Supplement 7 to the 03 series of amendments to UN Regulation No 129 (Enhanced Child Restraint systems)

ECE/TRANS/WP.29/GRSP/70, para. 20, based on ECE/TRANS/WP.29/GRSP/2021/7 as amended by Annex VI to the report

ECE/TRANS/WP.29/2022/65

131

Proposal for the 02 series of amendments to UN Regulation No 131 (Advanced Emergency Braking System)

ECE/TRANS/WP.29/GRVA/12, para. 72, based on ECE/TRANS/WP.29/GRVA/2022/7, as amended by GRVA-12-49 (reproduced in GRVA-12-50/Rev.1)

ECE/TRANS/WP.29/2022/76

135

Proposal for the 02 series of amendments to UN Regulation No 135 (Pole side impact)

ECE/TRANS/WP.29/GRSP/70, para. 23, based on ECE/TRANS/WP.29/GRSP/2021/21 not amended

ECE/TRANS/WP.29/2022/71

136

Proposal for the 01 series of amendments to UN Regulation No 136 (Electric vehicle L)

ECE/TRANS/WP.29/GRSP/70, para. 24, based on ECE/TRANS/WP.29/GRSP/2021/22, as amended by Annex VII to the report

ECE/TRANS/WP.29/2022/72

137

Proposal for Supplement 4 to the 01 series of amendments to UN Regulation No 137 (Frontal impact with focus on restraint systems)

ECE/TRANS/WP.29/GRSP/70, para. 26, based on ECE/TRANS/WP.29/GRSP/2021/23, not amended

ECE/TRANS/WP.29/2022/66

137

Proposal for Supplement 3 to the 02 series of amendments to UN Regulation No 137 (Frontal impact with focus on restraint systems)

ECE/TRANS/WP.29/GRSP/70, para. 26, based on ECE/TRANS/WP.29/GRSP/2021/23, not amended

ECE/TRANS/WP.29/2022/67

141

Proposal for Supplement 2 to the 01 series of amendments to UN Regulation No 141 (Tyre pressure monitoring system)

ECE/TRANS/WP.29/GRBP/73, based on ECE/TRANS/WP.29/GRBP/2022/2 as amended by GRBP-75-10 and GRBP-75-33

ECE/TRANS/WP.29/2022/87

145

Proposal for Supplement 2 to the original version to UN Regulation No 145 (ISOFIX anchorage systems, ISOFIX top tether anchorages and i-Size)

ECE/TRANS/WP.29/GRSP/70, para. 27, based on ECE/TRANS/WP.29/GRSP/2021/27 not amended

ECE/TRANS/WP.29/2022/68

148

Proposal for the 01 series of amendments to UN Regulation No 148 (Light signalling devices)

ECE/TRANS/WP.29/GRE/85, paras. 9 and 33, based on ECE/TRANS/WP.29/GRE/2021/13, as amended by GRE-85-09 and GRE-85-13, and ECE/TRANS/WP.29/GRE/2020/5/Rev.2, as amended by GRE-85-26

ECE/TRANS/WP.29/2022/92

149

Proposal for the 01 series of amendments to UN Regulation No 149 (Road illumination devices)

ECE/TRANS/WP.29/GRE/85, paras. 12 and 31, and ECE/TRANS/WP.29/GRE/83, para. 36, based on ECE/TRANS/WP.29/GRE/2021/14 as amended by GRE-85-09 and GRE-85-14, ECE/TRANS/WP.29/GRE/2021/18, as amended by GRE-85-33 and ECE/TRANS/WP.29/GRE/2020/13/Rev.1 as amended by GRE-83-51

ECE/TRANS/WP.29/2022/93,

WP.29-187-05

150

Proposal for the 01 series of amendments to UN Regulation No 150 (Retro-reflective devices)

ECE/TRANS/WP.29/GRE/85, para. 15, based ECE/TRANS/WP.29/GRE/2021/15, as amended by GRE-85-15

ECE/TRANS/WP.29/2022/94

157

Proposal for the 01 series of amendments to UN Regulation No 157 (Automated Lane Keeping Systems)

ECE/TRANS/WP.29/GRVA/12, para. 30, based on ECE/TRANS/WP.29/GRVA/2022/3, ECE/TRANS/WP.29/GRVA/2022/4, both amended by GRVA-12-52

GRVA-13-49e

ECE/TRANS/WP.29/2022/59/Rev.1

162

Proposal for Supplement 2 to the original series of amendments to UN Regulation No 162 (Immobilizers)

ECE/TRANS/WP.29/GRSG/102, based on GRSG-123-04

ECE/TRANS/WP.29/2022/110

New Regulation

Proposal for a new UN Regulation on Reverse Warning

ECE/TRANS/WP.29/GRBP/73, based on ECE/TRANS/WP.29/GRBP/2022/5, as amended by GRBP-75-13

ECE/TRANS/WP.29/2022/88


Global Technical Regulation No

Agenda item title

Document reference

2

Proposal for a new Amendment 5 to UN GTR No 2 (Worldwide Motorcycle emissions Test Cycle (WMTC))

ECE/TRANS/WP.29/GRPE/85, para. 50, based on ECE/TRANS/WP.29/GRPE/2022/6 as amended by GRPE-85-38 as reproduced in Addendum 2

ECE/TRANS/WP.29/2022/108

Proposal for a technical report on the development of a new Amendment 5 to UN GTR No 2 (Worldwide Motorcycle emissions Test Cycle (WMTC))

ECE/TRANS/WP.29/GRPE/85, para. 50

ECE/TRANS/WP.29/2022/109

New GTR

Proposal for a new UN GTR on durability of pollution-control devices for two- and three-wheelers

ECE/TRANS/WP.29/GRPE/85, para. 52, based on ECE/TRANS/WP.29/GRPE/2022/7, as amended by GRPE-85-39 as reproduced in Addendum 3

ECE/TRANS/WP.29/2022/106

Proposal for a technical report on the development of a new UN GTR on durability of pollution-control devices for two- and three-wheelers

ECE/TRANS/WP.29/GRPE/85, para. 52

ECE/TRANS/WP.29/2022/107


Miscellaneous

Agenda item title

Document reference

Consolidated Resolution

Proposal for a new Consolidated Resolution concerning Exhaust Ultra-Fine Particle Number Measurement For Heavy Duty Engines

ECE/TRANS/WP.29/GRPE/85, para. 46, based on ECE/TRANS/WP.29/GRPE/2021/17, as amended by GRPE-85-04-Rev.1 as reproduced in Addendum 1

ECE/TRANS/WP.29/2022/105

Authorisation

Authorization to develop Amendment 4 to UN GTR No 3 (Motorcycle braking)

ECE/TRANS/WP.29/2022/47/Rev.1

Guidelines

Proposal for Guidelines and Recommendations concerning Safety Requirements for Automated Driving Systems

ECE/TRANS/WP.29/2022/56

Master document

Proposal for the second iteration of the New Assessment/Test Method for Automated Driving – Master Document

ECE/TRANS/WP.29/GRVA/12, para. 24, based on ECE/TRANS/WP.29/GRVA/2022/2, as amended by GRVA-12-12 and reproduced in WP.29-186-09

ECE/TRANS/WP.29/2022/57

Guidelines

Proposal for the New Assessment/Test Method for Automated Driving (NATM) Guidelines for Validating Automated Driving System

GRVA-13-35

ECE/TRANS/WP.29/2022/58,

WP.29-187-08

Recommendation

Proposal for recommendations on uniform provisions concerning cyber security and software updates

ECE/TRANS/WP.29/GRVA/12, para. 47, based on ECE/TRANS/WP.29/GRVA/2022/5

ECE/TRANS/WP.29/2022/60

Interpretation document

Proposal for amendments to the Interpretation Document ECE/TRANS/WP.29/2021/59 for UN Regulation No 155 (Cyber security and cyber security management system)

ECE/TRANS/WP.29/GRVA/12, para. 46, based on ECE/TRANS/WP.29/2021/59, as amended by GRVA-12-37

ECE/TRANS/WP.29/2022/61

Guidelines

Proposal for amendments to the ‘specifications and application guidelines for the Unique Identifier (UI) module’ document

ECE/TRANS/WP.29/2019/77 ECE/TRANS/WP.29/1161, para. 70, based on ECE/TRANS/WP.29/2019/77, as amended by WP.29-185-13

ECE/TRANS/WP.29/2022/62


(1)  All documents referred to in the table are available at: (WP.29) World Forum for the Harmonization of Regulations (187th session) | UNECE.


22.6.2022   

EN

Official Journal of the European Union

L 166/145


COUNCIL DECISION (EU) 2022/970

of 16 June 2022

on the position to be taken on behalf of the European Union within the ACP-EU Committee of Ambassadors as regards the amendment of Decision No 3/2019 of the ACP-EU Committee of Ambassadors to adopt transitional measures pursuant to Article 95(4) of the ACP-EU Partnership Agreement

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 217 in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1)

The Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part (1) (the ‘ACP-EU Partnership Agreement’) was signed in Cotonou on 23 June 2000 and entered into force on 1 April 2003. In accordance with Decision No 3/2019 of the ACP-EU Committee of Ambassadors (2) (the ‘decision on transitional measures’), it is to be applied until 30 June 2022.

(2)

Pursuant to Article 95(4), first subparagraph, of the ACP-EU Partnership Agreement, negotiations towards a new ACP-EU Partnership Agreement (the ‘new Agreement’) were launched in September 2018. The new Agreement will not be ready to be applied by 30 June 2022, the expiry date of the current legal framework. It is therefore necessary to amend the decision on transitional measures in order to further extend the application of the provisions of the ACP-EU Partnership Agreement.

(3)

Article 95(4), second subparagraph, of the ACP-EU Partnership Agreement provides for the ACP-EU Council of Ministers to adopt any transitional measures that may be required until the new Agreement comes into force.

(4)

Pursuant to Article 15(4) of the ACP-EU Partnership Agreement, on 23 May 2019, the ACP-EU Council of Ministers delegated the powers to adopt the transitional measures to the ACP-EU Committee of Ambassadors (3). Therefore it is for the ACP-EU Committee of Ambassadors to amend the transitional measures pursuant to Article 95(4) of the ACP-EU Partnership Agreement.

(5)

It is appropriate to establish the position to be taken on the Union’s behalf in the ACP-EU Committee of Ambassadors, as the envisaged act will be binding on the Union.

(6)

The provisions of the ACP-EU Partnership Agreement will continue to be applied with the aim of maintaining continuity in relations between the Union and its Member States, on the one hand, and the ACP States, on the other. Accordingly, the amended transitional measures are not intended as amendments to the ACP-EU Partnership Agreement as provided for in Article 95(3) thereof,

HAS ADOPTED THIS DECISION:

Article 1

1.   The position to be taken on the Union’s behalf within the ACP-EU Committee of Ambassadors, pursuant to Article 95(4) of the ACP-EU Partnership Agreement, shall be to amend Decision No 3/2019 of the ACP-EU Committee of Ambassadors in order to extend the application of the provisions of the ACP-EU Partnership Agreement until 30 June 2023, or until the entry into force of the new Agreement or the provisional application between the Union and the ACP States of the new Agreement, whichever comes first.

2.   The provisions of the ACP-EU Partnership Agreement shall be applied in line with the purpose and objective of Article 95(4) thereof.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 16 June 2022.

For the Council

The President

O. DUSSOPT


(1)  OJ L 317, 15.12.2000, p. 3. The ACP-EU Partnership Agreement was amended by the Agreement signed in Luxembourg on 25 June 2005 (OJ L 209, 11.8.2005, p. 27) and by the Agreement signed in Ouagadougou on 22 June 2010 (OJ L 287, 4.11.2010, p. 3).

(2)  Decision No 3/2019 of the ACP-EU Committee of Ambassadors of 17 December 2019 to adopt transitional measures pursuant to Article 95(4) of the ACP-EU Partnership Agreement (OJ L 1, 3.1.2020, p. 3).

(3)  Decision No 1/2019 of the ACP-EU Council of Ministers of 23 May 2019 on the delegation of powers to the ACP-EU Committee of Ambassadors on the decision to adopt transitional measures pursuant to Article 95(4) of the ACP-EU Partnership Agreement (OJ L 146, 5.6.2019, p. 114).


GUIDELINES

22.6.2022   

EN

Official Journal of the European Union

L 166/147


GUIDELINE (EU) 2022/971 OF THE EUROPEAN CENTRAL BANK

of 19 May 2022

on the Centralised Securities Database and the production of securities issues statistics and repealing Guideline 2012/689/EU (ECB/2012/21) and Guideline (EU) 2021/834 (ECB/2021/15) (ECB/2022/25)

THE GOVERNING COUNCIL OF THE EUROPEAN CENTRAL BANK,

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

Having regard to the Statute of the European System of Central Banks and of the European Central Bank, and in particular Articles 5.1, 12.1 and 14.3 thereof,

Having regard to Council Regulation (EC) No 2533/98 of 23 November 1998 concerning the collection of statistical information by the European Central Bank (1), and in particular Article 4 thereof,

Having regard to the contribution of the General Council of the European Central Bank,

Whereas:

(1)

The Centralised Securities Database (CSDB) is a single information technology infrastructure operated jointly by the members of the European System of Central Banks (ESCB), including national central banks of the Member States whose currency is not the euro (hereinafter ‘non-euro area NCBs’) where such non-euro area NCBs voluntarily participate in the operation of the CSDB. The CSDB stores item-by-item data, in particular, data on securities, their issuers, prices and ratings. The main processes of the CSDB’s operation comprise input data provision, processing of that input data, carrying out data quality management (DQM) and production and dissemination of output data consisting of item-by-item data and aggregate information. A number of changes to these processes require the adoption of a new Guideline to ensure that there are clear and certain arrangements for the governance of the CSDB. In the interest of legal certainty, Guideline 2012/689/EU of the European Central Bank (ECB/2012/21) (2) and Guideline (EU) 2021/834 of the European Central Bank (ECB/2021/15) (3) , which to date have governed the data quality management framework of the CSDB and the reporting of statistical information on securities issues, should be repealed.

(2)

To enhance monetary policy and financial stability analyses for the euro area and the Union, to contribute to the production of secondary statistics, to fulfil the euro area reporting commitments on debt securities issuance statistics in the context of the G20 Data Gaps Initiative and to assess the role of the euro in international financial markets, monthly securities issues statistics covering stock and flow aggregates of securities issuances are produced from CSDB item-by-item data (hereinafter ‘CSEC aggregate statistics’). Accordingly, CSEC aggregate statistics should be compiled in the CSDB, and national central banks of the Member States whose currency is the euro (hereinafter the ‘NCBs’) and the European Central Bank (ECB) should be responsible for the verification of CSEC aggregate statistics and for the DQM of the underlying CSDB item-by-item data.

(3)

Providing input data for the CSDB involves collecting data from various sources and transmitting it to the ECB via the CSDB. This collection by the ECB is necessary in order to undertake the tasks of the ESCB, particularly those regarding monetary policy and the stability of the financial system. These sources include the NCBs and the non-euro area NCBs, ECB-internal sources, certain commercial data providers, administrative sources, and the public domain.

(4)

To link the security-by-security data collected from different sources and to avoid duplicate records, all securities that are transmitted to the CSDB should be identified uniquely by an International Securities Identification Number (ISIN code).To ensure the correct grouping of the input data provided by NCBs and accurate linking of the CSDB data with other ESCB statistical information, NCBs should provide, as part of their input reference data on issuers, at least one linking entity identifier that is included in the Register of Institutions and Affiliates Database (RIAD). Furthermore, to facilitate the correct grouping of issuer reference data from different sources and accurate linking with other ESCB statistical information, a Legal Entity Identifier (LEI) should be provided when available.

(5)

The overall quality of CSDB item-by-item data can only be assessed at the output level, rather than at the level of individual sets of input data. To ensure the completeness, accuracy and consistency of output data, it is necessary to define a DQM framework to be applied to output feed data, which is a subset of output data that can be used to support the production of statistics or other uses.

(6)

The CSDB DQM framework should be applied to output feed data regardless of the source of input data. It should lay down the responsibilities of the NCBs and the ECB for the quality of output data in the CSDB. In order to ensure the high quality of output feed data and CSEC aggregate statistics, and to enable the ECB to provide snapshots of output feed data and the CSEC aggregate statistics in a timely manner, NCBs and the ECB should verify output feed data and CSEC aggregate statistics by a specified date.

(7)

To ensure the high quality of CSDB item-by-item data and of historical CSEC aggregate statistics, and to support the alignment of NCBs’ national security-by-security databases and the CSDB, NCBs that have improved their input data should provide revised input data files to the CSDB or use the CSDB system to correct the data.

(8)

Since the CSDB is operated jointly by all ESCB members, they should all aim to follow the same DQM standards. Where an NCB would like to conduct DQM that affects the CSDB data related to residents in other countries, it should coordinate with the NCBs and the non-euro area NCBs and with the ECB, as relevant, to clearly define the boundaries of such DQM. Moreover, non-euro area NCBs are in the best position to carry out DQM on the data related to issuers residing in their respective Member States. While it is recognised that guidelines adopted by the ECB may not impose any obligations on non-euro area NCBs, Article 5 of the Statute of the European System of Central Banks and of the European Central Bank applies to both NCBs and non-euro area NCBs. This implies an obligation on non-euro area NCBs to therefore design and implement all the measures that they consider appropriate in order to carry out DQM of CSDB output data and CSEC aggregate statistics in accordance with this Guideline. In addition, for the purposes of enabling the ECB to obtain a comprehensive overview of the statistical information collected and to carry out relevant analyses, the national central banks of non-euro area Member States that adopt the euro should be required to provide the ECB with statistical information covering a specified period prior to their adoption of the euro.

(9)

To improve the quality of output data, data source management (DSM) should be carried out with the aim of identifying and correcting repetitive and/or structural mistakes in input data. DSM should be carried out by the ECB in relation to input data provided by commercial data sources and by NCBs in relation to their own input data.

(10)

Common rules should be established for the publication by NCBs of aggregate statistics using CSDB data to ensure an orderly release of the related key aggregates.

(11)

It is necessary to set up a procedure to carry out technical amendments to the annexes to this Guideline in an effective manner, provided that such amendments neither change the underlying conceptual framework nor affect the reporting and DQM burden,

HAS ADOPTED THIS GUIDELINE:

Article 1

Definitions

For the purposes of this Guideline the following definitions shall apply:

(1)

‘Centralised Securities Database’ or ‘CSDB’ means the Centralised Securities Database set up by the European System of Central Banks (ESCB);

(2)

‘input data’ means any data provided to the CSDB from one or more of the following data sources: a) both national central banks of the Member States whose currency is the euro (hereinafter the ‘NCBs’) and national central banks of the Member States whose currency is not the euro (hereinafter the ‘non-euro area NCBs’; b) European Central Bank-internal sources; c) commercial data providers; d) administrative sources; e) the public domain;

(3)

‘input provision bracket’ means a period of working days each calendar month, which is defined by the European Central Bank (ECB) and during which the NCBs may provide input data to the CSDB;

(4)

‘output data’ means item-by-item data that are automatically derived in the CSDB by compounding input data into complete, high quality single data records;

(5)

‘output feed data’ means the subset of item-by-item output data and characteristics listed in Annex III to this Guideline that support the production of statistics or other uses;

(6)

‘CSEC aggregate statistics’ means aggregated securities issues statistics covering stock and flow aggregates of securities issuances produced from item-by-item CSDB output data as specified in Annex IV to this Guideline;

(7)

‘Data Quality Management’ or ‘DQM’ means the activity of ensuring, verifying and maintaining the quality of output feed data and CSEC aggregate statistics through the use and application of DQM targets, DQM metrics, DQM thresholds and specific DQM workflows;

(8)

‘Data Source Management’ or ‘DSM’ means the activity of identifying and correcting directly with a data provider repetitive and/or structural mistakes in input data;

(9)

‘initial DQM’ means DQM of item-by-item output feed data and CSEC aggregate statistics, covering the end-month preview for the most recent reference month and carried out on a monthly basis;

(10)

‘regular DQM’ means DQM of item-by-item output feed data and CSEC aggregate statistics, covering the reference months prior to the month covered by initial DQM and carried out on a monthly basis, taking into account non-CSDB benchmark data provided by various data sources with a view to ensuring that CSDB output data quality satisfies the requirements for CSDB feed data;

(11)

‘DQM target’ means a benchmark for assessing the quality of output feed data, as specified in Annex II to this Guideline;

(12)

‘DQM metric’ means a statistical indicator measuring the level to which a certain DQM target has been reached, as specified in Annex II to this Guideline;

(13)

‘DQM threshold’ means the minimum level of verification work to be conducted in order to satisfy the requirements of the DQM framework for a DQM target;

(14)

‘DQM exception’ means a possible data quality issue that is identified via a specified rule and for which the data needs to be confirmed or corrected in order to reach the respective DQM threshold;

(15)

‘DQM workflow’ means a technical process applied for the correction of input data in order to comply with a DQM threshold;

(16)

‘end-month preview’ means a daily update of output data and of DQM metrics which produces an approximation of output data for the forthcoming end-month status;

(17)

‘initial CSEC aggregate statistics’ means CSEC aggregate statistics covering the most recent reference month;

(18)

‘regular CSEC aggregate statistics’ means CSEC aggregate statistics covering the reference months prior to the month covered by initial CSEC aggregate statistics;

(19)

‘CSEC priority series’ means the lowest-level CSEC aggregate statistics that are subject to the DQM requirements, as specified in Annex II and Annex IV to this Guideline;

(20)

‘reference month’ means the calendar month to which the relevant data or statistics refer;

(21)

‘working day’ is a complete day which is not an ECB public holiday, as published on the ECB’s website;

(22)

‘verification’ means the process of checking CSDB output feed data as well as CSEC aggregate statistics and, if necessary, correcting CSDB input data, hereby applying the DQM workflow;

(23)

‘resident’ has the meaning defined in Regulation (EU) No 549/2013 of the European Parliament and of the Council (4);

(24)

‘ISIN code’ means the International Securities Identification Number, as defined by the International Standards Organization (ISO) in ISO 6166;

(25)

‘linking entity identifier’ means an entity identifier that is included both in the CSDB and in the ESCB’s Register of Institutions and Affiliates Data (RIAD) data set and that is either a RIAD code, another national entity identifier used by the relevant NCB or non-euro area NCB, a Legal Entity Identifier (LEI) defined by ISO 17442, or another entity identifier commonly accepted by the ECB and the relevant NCB or non-euro area NCB.

Article 2

Subject matter and scope

This Guideline establishes a framework for the production of securities data and securities issues statistics in the CSDB. The aim of this framework is to ensure the completeness, accuracy and consistency of CSDB output data and CSEC aggregate statistics by consistently applying rules on the provision of input data and DQM and DSM for such data.

Article 3

Role of the ECB and NCBs

1.   The ECB, with the assistance of the NCBs, shall define the CSDB’s operational processes; compile the CSEC aggregate statistics; and produce output data, including output feed data.

2.   In accordance with this Guideline, the NCBs shall:

(a)

provide input data on securities issued by residents in their Member States to the CSDB where they have such data readily available;

(b)

conduct the DQM of the data related to issuers resident in their Member States;