Commission Implementing Regulation (EU) 2026/400

Contents

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^note, and in particular Article 44(5), first subparagraph, thereof,Whereas:

(1)On 25 July 2018, CID LINES NV submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ of product-types 2 and 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-RF039183-42 in the Register for Biocidal Products.

(2)‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ contains chlorocresol 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 for product-types 2 and 3.

(3)On 7 January 2022, 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 Agency.

(4)On 18 November 2022, the Agency submitted to the Commission its opinion^note, the draft summary of the biocidal product characteristics (‘SPC’) of ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ 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 concluded that for the biocidal product family ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ the conditions of Article 19(6) of Regulation (EU) No 528/2012 are met and proposed the biocidal product family to be authorised, for the uses described under section 2.1 of the opinion, subject to compliance with the proposed SPC. For one of the uses (use # 7.7 as listed in the Agency opinion) as a concentrated animal skin disinfectant (product type 3) used by spraying by professional users, the Agency opinion did not provide a conclusion due to an ongoing discussion at regulatory level about the consequences of the exceedance of maximum residue limits.

(6)On 7 December 2022, 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)Article 19(1), point (b)(iii), of Regulation (EU) No 528/2012 establishes as a condition for authorisation that a biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects. In accordance with Article 19(1), point (e), of Regulation (EU) No 528/2012, biocidal products are to be authorised provided that, where appropriate, maximum residue limits (MRLs) for food and feed or specific migration limits or limits for the residual content in food contact materials have been established in accordance with relevant Union legislation.

(8)Article 18(1), point (b), of Regulation (EC) No 396/2005 of the European Parliament and of the Council^note sets a default MRL of 0,01 mg/kg for pesticide residues for products for which no specific MRL is set out in Annexes II or III to that Regulation. However, in accordance with Article 3(2), point (c), of Regulation (EC) No 396/2005, pesticide residues are residues, including active substances, metabolites and/or breakdown or reaction products of active substances currently or formerly used in plant protection products as defined in Article 2, point 1, of Council Directive 91/414/EEC^note, which are present in or on the products covered by Annex I to Regulation (EC) No 396/2005, including in particular those which may arise as a result of use in plant protection, in veterinary medicine and as a biocide. After analysis, it appears that chlorocresol was never used as an active substance in plant protection products under Directive 91/414/EEC or Regulation (EC) No 1107/2009 of the European Parliament and of the Council^note. As there is no evidence that chlorocresol is currently or was formerly used in plant protection products, the Commission concludes that chlorocresol does not fall within the scope of Regulation (EC) No 396/2005 and that the default MRL value of 0,01 mg/kg set out in Article 18(1), point (b), of that Regulation does not apply to the biocidal active substance chlorocresol.

(9)For the use #7.7 of ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’, the opinion provided by the Agency identified a case where residues of chlorocresol in products of animal origin would exceed the level of 0,01 mg/kg but specified no risks for human health. Specifically, no immediate or delayed unacceptable effects of chlorocresol as such, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects were identified.

(10)The active substance chlorocresol has also been evaluated by the Committee for Veterinary Medicinal Products under Council Regulation (EEC) No 2377/90^note which was replaced by Regulation (EC) 470/2009 of the European Parliament and of the Council^note and it concluded that there is no need to establish a MRL for chlorocresol in all food-producing species as chlorocresol is considered to have low toxicity, is rapidly metabolised and excreted, with no potential to accumulate in tissues, and has been safely used in human medicine for many years^note.

(11)The Commission therefore considers that for the use #7.7 the conditions of Article 19(1), point (b)(iii), of Regulation (EU) No 528/2012 are fulfilled, taking into account, that there is no dietary risk for the consumer arising from the use of the product and that consumer exposure does not exceed the acceptable daily intake. The Commission also considers that the condition of Article 19(1), point (e), of Regulation (EU) No 528/2012 is met as chlorocresol is classified as a substance for which no MRL is required pursuant to Commission Regulation (EU) No 37/2010^note and it is not within the scope of Regulation (EC) No 396/2005.

(12)As the draft SPC provided to the Commission by the Agency did not include the use #7.7, on 22 August 2024 the Commission requested the Agency to provide a revised draft SPC including use #7.7 and its use conditions and an updated version of the product assessment report and a revised Agency opinion in accordance with Article 75(1), point (g), of Regulation (EU) No 528/2012.

(13)On 6 March 2025 the Agency provided its revised opinion^note (‘revised Agency opinion’) and an updated product assessment report to the Commission. The revised draft SPC included additional editorial changes, and a correction, namely that use #7.4 (as listed in the revised Agency opinion), as concentrated disinfectants for use on instruments/equipment by veterinarians (PT2) by spraying or immersion, is not proposed for authorisation due to risks to human health and the environment that were already identified during the initial assessment.

(14)The Commission concurs with the revised Agency opinion and considers it therefore appropriate to grant a Union authorisation for ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’, for the uses proposed in the overall conclusions of the revised Agency opinion, in accordance with the revised SPC.

(15)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-0029989-0000 is hereby granted to CID LINES NV for the making available on the market and use of the biocidal product family ‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 19 March 2026 to 29 February 2036.

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.

Summary of product characteristics for a biocidal product family

Chlorocresol based products

Product type(s)

PT03: Veterinary hygiene

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

Authorisation number EU-0029989-0000

R4BP asset number EU-0029989-0000

Part I — first information level

1. Administrative information

1.1. Family name

Name	CHLOROCRESOL BASED PRODUCTS

1.2. Product type(s)

Product type(s)

PT03: Veterinary hygienePT02: Disinfectants and algaecides not intended for direct application to humans or animals

1.3. Authorisation holder

Name and address of the authorisation holder	Name	CID LINES NV
Address	Waterpoortstraat 2 8900 Ieper BE
Authorisation number		EU-0029989-0000
R4BP asset number		EU-0029989-0000
Date of the authorisation		19 March 2026
Expiry date of the authorisation		29 February 2036

1.4. Manufacturer(s) of the product

Name of manufacturer	CID LINES NV
Address of manufacturer	Waterpoortstraat 2 8900 Ieper Belgium
Location of manufacturing sites	CID LINES NV site 1 Waterpoortstraat 2 8900 Ieper Belgium

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

Active substance	Chlorocresol
Name of manufacturer	Lanxess Deutschland GmbH
Address of manufacturer	Kennedyplatz 1 50569 Köln Germany
Location of manufacturing sites	Lanxess Deutschland GmbH site 1 Chempark D-47829 Krefeld Germany

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 (%)
Chlorocresol		Active substance	59-50-7	200-431-6	0,49 - 24,9 % (w/w)
Propan-2-ol	Propan-2-ol	Non-active substance	67-63-0	200-661-7	0 - 12 % (w/w)
Pine oil	Pine oil	Non-active substance	94266-48-5	304-455-9	0 - 8 % (w/w)
Acetone	Acetone	Non-active substance	67-64-1	200-662-2	0 - 10 % (w/w)
Dimethylether	Dimethylether	Non-active substance	115-10-6	204-065-8	0 - 50 % (w/w)
Propan-1-ol	Propan-1-ol	Non-active substance	71-23-8	200-746-9	0 - 23 % (w/w)
Formic acid	Formic acid	Non-active substance	64-18-6	200-579-1	0 - 11 % (w/w)
Phosphoric acid	Phosphoric acid	Non-active substance	7664-38-2	231-633-2	0 - 25 % (w/w)
Salicylic acid	Salicylic acid	Non-active substance	69-72-7	200-712-3	0 - 8 % (w/w)
Propionic acid	Propionic acid	Non-active substance	79-09-4	201-176-3	0 - 37 % (w/w)

2.2. Type(s) of formulation

Formulation type(s)

SL Soluble concentrate

Part II — second information level meta spc(s)

1. Meta spc 1 administrative information

1.1. Meta SPC 1 identifier

Identifier

Meta SPC: Meta SPC 1

1.2. Suffix to the authorisation number

Number

1-1

1.3. Product type(s)

Product type(s)

PT03: Veterinary hygiene

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 (%)
Chlorocresol		Active substance	59-50-7	200-431-6	24 - 24 % (w/w)
Propan-1-ol	Propan-1-ol	Non-active substance	71-23-8	200-746-9	10 - 10 % (w/w)

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

Formulation type(s)

SL Soluble concentrate

3. Hazard and precautionary statements of the meta spc 1

Hazard statements

H225: Highly flammable liquid and vapour.H314: Causes severe skin burns and eye damage.H317: May cause an allergic skin reaction.H335: May cause respiratory irritation.H412: Harmful to aquatic life with long lasting effects.

Precautionary statements

P260: Do not breathe vapours.P271: Use only outdoors or in a well-ventilated area.P272: Contaminated work clothing should not be allowed out of the workplace.P280: Wear protective gloves.P264: Wash contaminated body area thoroughly after handling.P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].P363: Wash contaminated clothing before reuse.P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.P310: Immediately call a POISON CENTER.P321: Specific treatment (see instructions on this label).P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.P403+P233: Store in a well-ventilated place. Keep container tightly closed.P405: Store locked up.P273: Avoid release to the environment.P501: Dispose of contents in accordance with local regulation.P501: Dispose of container in accordance with local regulation.P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.P280: Wear protective clothing.P280: Wear eye protection.P280: Wear face protection.P260: Do not breathe spray.P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].P333+P313: If skin irritation or rash occurs: Get medical attention.P310: Immediately call a doctor.P333+P313: If skin irritation or rash occurs: Get medical advice.

4. Authorised use(s) of the meta spc

4.1. Use description

Table 1
Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no dataCommon name: bacteriaDevelopment stage: no dataScientific name: no dataCommon name: yeastsDevelopment stage: no dataScientific name: no dataCommon name: fungiDevelopment stage: no dataScientific name: no dataCommon name: virusesDevelopment stage: no dataScientific name: no dataCommon name: endoparasites: parasitic protozoaDevelopment stage: no dataScientific name: no dataCommon name: helminth eggsDevelopment stage: eggs
Field(s) of use	indoor useVeterinary fieldConcentrated surface disinfectant for non-porous surfaces and equipment in veterinary field for poultry, pig and cattle houses
Application method(s)	Method: Automated and manual sprayingDetailed description:-
Application rate(s) and frequency	Application Rate: 250 mL/m2 Dilution (%): 1%, 2% or 4% v/v (depending on the target organism)Number and timing of application:For automated and manual sprayingMandatory target organisms:Bacteria and yeasts: 1% v/v dilution of the product, 60 minutesOther target organisms:Fungi : 2% v/v dilution of the product, 60 minutesVirus: 1% v/v dilution of the product, 60 minutesEndoparasites: helminth eggs: 2% v/v dilution of the product, 120 minutesFor automated spraying only,Other target organisms:Endoparasites: parasitic protozoa: 4% v/v dilution of the product, 120 minutesFrequency: 2 to 13 times per year
Category(ies) of users	professional
Pack sizes and packaging material	1100 L or 1-1100 kg in HDPE (High Density Polyethylene) container

4.1.1. Use-specific instructions for use

4.1.2. Use-specific risk mitigation measures

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

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

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

5. General directions for use of the meta spc 1

5.1. Instructions for use

—Always read the label or leaflet before use and respect all the instructions provided.

—Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).

—Precleaning of surfaces required before using disinfectants.

—Spray a recommended solution of the product within the stable on walls and floors which might come in contact with the animals (0.25 l/m²).

—Apply only on non porous surfaces.

—Apply 250 ml/m² on the surface to be disinfected.

The authorisation holder should give indications of application of the product (dilution, quantity applied on surface, etc …) on the label in order to guarantee the safe and efficient use of the product during its application. The volume of product to be diluted and the specified volume of water should be clearly indicated on the label.

5.2. Risk mitigation measures

—For automated spraying:

—The professional user must not stay in the room during the automated application.

—Wear substance/task appropriate respirator, protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information), chemical goggles meeting the requirements of EN 166 or equivalent and protection coverall (material to be specified by the authorisation holder within the product information) during mixing and loading of the product and gloves during cleaning of spray equipment.

—After disinfection of equipment, do not re-enter in room during 1 hour.

—After disinfection of surface, do not re-enter in room during 20 minutes.

—For manual spraying:

—Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information), a protective impermeable coverall (at least category III type 4, in accordance with EN-14605 or equivalent) (coverall material to be specified by the authorisation holder within the product information), a respiratory protective equipment (RPE) with an assigned protection factor of at least 4 (filter type (code letter, colour) to be specified by the authorisation holder within the product information) during mixing and loading and spraying of the product, chemical goggles meeting the requirements of EN 166 or equivalent during mixing and loading and gloves during cleaning of spray equipment.

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

Common RMM :

—The following RMMs have to be considered during mixing and loading step of the products:

—Manual phases should be reduced to the strict minimum;

—Regular cleaning of equipment and work area;

—Avoidance of contact with contaminated tools and objects.

—Apply the product on all the surfaces except the ceiling

—For pig breeding: For use only in animal housings, where lying areas of suckling piglets are covered with mats, strew or any other suitable material

—Do not use in breeding stations or other breeding areas for chicks.

—Do not use the product for the treatment of duck housings.

—Do not apply the product on surfaces which may come into contact with children.

—Do not introduce animals until a total drying.

—Do not touch or manipulate before total drying of surface.

—Do not apply the treatment in the presence of domestic animals.

—Only use in empty animal housing.

—Rinse treated surfaces with drinking water after application

—Remove all food, feed and drinks prior to treatment

—Do not use in animal housings where exposure to a sewage treatment plant (STP) or direct emission to surface water cannot be prevented.

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

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse.

Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 and or ambulance for medical assistance.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.

If symptoms: Call 112 and or ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 and or ambulance for medical assistance.

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 nor down the drains.

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

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

Shelf-life: 3 years

Keep out of reach of children and non-target animals

6. Other information

The full titles of the EN standards referenced in sections “Use-specific risk mitigation measures” are:

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

EN 14605 - Protective clothing against liquid chemicals

EN 166 – Eye protection

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

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)	KC 5000	Market area: EU
MS Ascar Cocci Des	Market area: EU
Q Farm Endo Des	Market area: EU
Stalldes Spezial	Market area: EU
Authorisation number		EU-0029989-0001 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Chlorocresol		Active substance	59-50-7	200-431-6	24 % (w/w)
Propan-1-ol	Propan-1-ol	Non-active substance	71-23-8	200-746-9	10 % (w/w)

1. Meta spc 2 administrative information

1.1. Meta SPC 2 identifier

Identifier

Meta SPC: Meta SPC 2

1.2. Suffix to the authorisation number

Number

1-2

1.3. Product type(s)

Product type(s)

PT03: Veterinary hygiene

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 (%)
Chlorocresol		Active substance	59-50-7	200-431-6	24,9 - 24,9 % (w/w)
Phosphoric acid	Phosphoric acid	Non-active substance	7664-38-2	231-633-2	25 - 25 % (w/w)
Propionic acid	Propionic acid	Non-active substance	79-09-4	201-176-3	37 - 37 % (w/w)

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

Formulation type(s)

SL Soluble concentrate

3. Hazard and precautionary statements of the meta spc 2

Hazard statements

H226: Flammable liquid and vapour.H290: May be corrosive to metals.H314: Causes severe skin burns and eye damage.H317: May cause an allergic skin reaction.H335: May cause respiratory irritation.H412: Harmful to aquatic life with long lasting effects.H302: Harmful if swallowed.

Precautionary statements

P260: Do not breathe vapours.P264: Wash contaminated body area thoroughly after handling.P270: Do not eat, drink or smoke when using this product.P271: Use only outdoors or in a well-ventilated area.P272: Contaminated work clothing should not be allowed out of the workplace.P280: Wear protective gloves.P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.P333+P313: If skin irritation or rash occurs: Get medical advice.P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].P363: Wash contaminated clothing before reuse.P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.P310: Immediately call a POISON CENTER.P321: Specific treatment (see Instructions on this label).P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.P403+P233: Store in a well-ventilated place. Keep container tightly closed.P405: Store locked up.P273: Avoid release to the environment.P501: Dispose of contents in accordance with local regulation.P501: Dispose of container in accordance with local regulation.P234: Keep only in original packaging.P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.P260: Do not breathe spray.P280: Wear protective clothing.P280: Wear eye protection.P280: Wear face protection.P312: Call a POISON CENTER if you feel unwell.P312: Call a doctor if you feel unwell.P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.P333+P313: If skin irritation or rash occurs: Get medical attention.P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].P310: Immediately call a doctor.

4. Authorised use(s) of the meta spc

4.1. Use description

Table 1
Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no dataCommon name: bacteriaDevelopment stage: no dataScientific name: no dataCommon name: yeastsDevelopment stage: no dataScientific name: no dataCommon name: virusesDevelopment stage: no dataScientific name: no dataCommon name: endoparasites: parasitic protozoaDevelopment stage: no dataScientific name: no dataCommon name: helminth eggsDevelopment stage: no data
Field(s) of use	indoor useVeterinary fieldConcentrated surface disinfectant for non porous surfaces and equipment in veterinary field for poultry, pig and cattle houses.
Application method(s)	Method: Automated and manual sprayingDetailed description:-
Application rate(s) and frequency	Application Rate: 250 mL/m² Dilution (%): 1.5%, 2%, 3,5% or 4% v/v (depending on the target organism)Number and timing of application:For automated and manual spraying,Mandatory target organisms:Bacteria and yeasts: 1,5% v/v dilution of the product, 30 minutesOther target organisms:Endoparasites: helminth eggs 2 % v/v dilution of the product, 120 minutesFor automated spraying only,Other target organisms:Virus: 3,5% v/v dilution of the product, 30 minutesEndoparasites: parasitic protozoa: 4 % v/v dilution of the product, 120 minutesFrequency: 2 to 13 times per year
Category(ies) of users	professional
Pack sizes and packaging material	1-1100 L or 1-1100 kg in HDPE container

4.1.1. Use-specific instructions for use

4.1.2. Use-specific risk mitigation measures

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

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

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

5. General directions for use of the meta spc 2

5.1. Instructions for use

—Always read the label or leaflet before use and respect all the instructions provided.

—Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).

—Precleaning of surfaces required before using disinfectants.

—Spray a recommended solution of the product within the stable on walls and floors which might come in contact with the animals (0.25 L/m²).

—Apply 250 mL/m² on the surface to be disinfected.

—Apply only on non porous surfaces.

5.2. Risk mitigation measures

—For automated spraying:

—The professional must not stay in the room during the automated application.

—Wear respiratory protective equipment (RPE) with an assigned protection factor of at least 10 (filter type (code letter, colour) to be specified by the authorisation holder within the product information), protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information), chemical goggles meeting the requirements of EN 166 or equivalent and protection coverall (material to be specified by the authorisation holder within the product information) during mixing and loading of the product and gloves during cleaning of spray equipment.

—After disinfection of equipment, do not re-enter in room during 160 minutes.

—After disinfection of surface, do not re-enter in room during 70 minutes.

—Apply the product on all the surfaces except the ceiling

—For pig breeding: For use only in animal housings, where lying areas of suckling piglets are covered with mats, strew or any other suitable material

—Do not use in breeding stations or other breeding areas for chicks.

—Do not use the product for the treatment of duck housings.

—The following RMMs have to be considered during mixing and loading of the products:

—Manual phases should be reduced to the strict minimum;

—Regular cleaning of equipment and work area;

—Avoidance of contact with contaminated tools and objects.

—For manual spraying:

—Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information), a protective impermeable coverall (at least category III type 4, EN-14605 or equivalent) (coverall material to be specified by the authorisation holder within the product information), during mixing and loading and spraying of the product, chemical goggles in accordance with EN 166 or equivalent and a respiratory protective equipment (RPE) with an assigned protection factor of at least 10 (filter type (code letter, colour) to be specified by the authorisation holder within the product information during mixing and loading and gloves during cleaning of spray equipment

—After disinfection of equipment, do not re-enter in room during 100 minutes.

—After disinfection of surface, do not re-enter in room during 40 minutes.

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

—Do not apply the product on surfaces which may come into contact with children.

—Do not introduce animals until a total drying.

—Do not touch or manipulate before total drying of surface.

—Do not apply the treatment in the presence of domestic animals.

—Only use in empty animal housing.

—Rinse treated surfaces with drinking water after application

—Remove all food, feed and drinks prior to treatment

—Do not use in animal housings where exposure to a STP or direct emission to surface water cannot be prevented.

Common RMM :

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

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse.

Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE

or a doctor.

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 and or ambulance for medical assistance.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.

If symptoms: Call 112 and or ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 and or ambulance for medical assistance.

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 nor down the drains.

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

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

Shelf-life: 2 years

Keep out of reach of children and non-target animals

6. Other information

The full titles of the EN standards referenced in sections “Use-specific risk mitigation measures” are:

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

EN 14605 - Protective clothing against liquid chemicals

EN 166 – Eye protection

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

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)	KC 6000	Market area: EU
Authorisation number		EU-0029989-0002 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Chlorocresol		Active substance	59-50-7	200-431-6	24,9 % (w/w)
Phosphoric acid	Phosphoric acid	Non-active substance	7664-38-2	231-633-2	25 % (w/w)
Propionic acid	Propionic acid	Non-active substance	79-09-4	201-176-3	37 % (w/w)

1. Meta spc 3 administrative information

1.1. Meta SPC 3 identifier

Identifier

Meta SPC: Meta SPC 3

1.2. Suffix to the authorisation number

Number

1-3

1.3. Product type(s)

Product type(s)

PT03: Veterinary hygiene

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 (%)
Chlorocresol		Active substance	59-50-7	200-431-6	24,9 - 24,9 % (w/w)
Propan-2-ol	Propan-2-ol	Non-active substance	67-63-0	200-661-7	12 - 12 % (w/w)
Propan-1-ol	Propan-1-ol	Non-active substance	71-23-8	200-746-9	20 - 20 % (w/w)
Salicylic acid	Salicylic acid	Non-active substance	69-72-7	200-712-3	8 - 8 % (w/w)

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

Formulation type(s)

SL Soluble concentrate

3. Hazard and precautionary statements of the meta spc 3

Hazard statements

H226: Flammable liquid and vapour.H314: Causes severe skin burns and eye damage.H317: May cause an allergic skin reaction.H335: May cause respiratory irritation.H336: May cause drowsiness or dizziness.H361d: Suspected of damaging the unborn child.H412: Harmful to aquatic life with long lasting effects.H290: May be corrosive to metals.

Precautionary statements

P201: Obtain special instructions before use.P202: Do not handle until all safety precautions have been read and understood.P271: Use only outdoors or in a well-ventilated area.P272: Contaminated work clothing should not be allowed out of the workplace.P280: Wear protective gloves.P264: Wash contaminated body area thoroughly after handling.P308+P313: IF exposed or concerned: Get medical advice.P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.P333+P313: If skin irritation or rash occurs: Get medical advice.P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].P363: Wash contaminated clothing before reuse.P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.P310: Immediately call a POISON CENTER.P321: Specific treatment (see Instructions on this label).P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.P403+P233: Store in a well-ventilated place. Keep container tightly closed.P405: Store locked up.P273: Avoid release to the environment.P501: Dispose of contents in accordance with local regulation.P501: Dispose of container in accordance with local regulation.P234: Keep only in original packaging.P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.P280: Wear protective clothing.P280: Wear eye protection.P280: Wear face protection.P308+P313: IF exposed or concerned: Get medical attention.P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].P337+P313: If eye irritation persists: Get medical attention.P310: Immediately call a doctor.P333+P313: If skin irritation or rash occurs: Get medical attention.P260: Do not breathe dust.P260: Do not breathe fume.P260: Do not breathe gas.P260: Do not breathe mist.P260: Do not breathe vapours.P260: Do not breathe spray.

4. Authorised use(s) of the meta spc

4.1. Use description

Table 1
Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no dataCommon name: bacteriaDevelopment stage: no dataScientific name: no dataCommon name: yeastsDevelopment stage: no dataScientific name: no dataCommon name: virusesDevelopment stage: no dataScientific name: no dataCommon name: Endoparasites: parasitic protozoaDevelopment stage: no dataScientific name: no dataCommon name: helminth eggsDevelopment stage: no data
Field(s) of use	indoor useVeterinary fieldConcentrated surface disinfectant for non porous surfaces and equipment in veterinary field for poultry, pig and cattle houses.
Application method(s)	Method: Automated and manual sprayingDetailed description:-
Application rate(s) and frequency	Application Rate: 250 mL/m² Dilution (%): 1%, 2%, 3,5% or 4% (depending on the target organism)Number and timing of application:For automated and manual spraying,Mandatory target organisms:Bacteria and yeasts: 1% v/v dilution of the product, 30 minutesFor automated spraying only,Other target organisms:Virus: 3.5% v/v dilution of the product, 30 minutesEndoparasites: parasitic protozoa: 4 % v/v dilution of the product, 120 minutesEndoparasites: helminth eggs: 2 % v/v dilution of the product, 120 minutesFrequency: 2 to 13 times per year
Category(ies) of users	professional
Pack sizes and packaging material	1-1100 L or 1-1100 kg in HDPE container

4.1.1. Use-specific instructions for use

4.1.2. Use-specific risk mitigation measures

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

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

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

5. General directions for use of the meta spc 3

5.1. Instructions for use

—Always read the label or leaflet before use and respect all the instructions provided.

—Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).

—Precleaning of surfaces required before using disinfectants.

—Spray a recommended solution of the product within the stable on walls and floors which might come into contact with the animals (0.25 L/m²).

—Apply 250 ml/m² on the surface to be disinfected.

—Apply only on non porous surfaces.

5.2. Risk mitigation measures

—For automated spraying:

—The professional must not stay in the room during the automated application.

—Wear substance/task appropriate respirator, protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information), chemical goggles in accordance with EN 166 or equivalent and protection coverall (coverall material to be specified by the authorisation holder within the product information) during mixing and loading of the product and gloves during cleaning of spray equipment.

—After disinfection of equipment, do not re-enter in room during 1 hour.

—After disinfection of surface, do not re-enter in room during 20 minutes.

—For manual spraying:

—Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information), a protective impermeable coverall (at least category III type 4, EN-14605 or equivalent) (coverall material to be specified by the authorisation holder within the product information) during mixing and loading and spraying of the product, chemical goggles in accordance with EN 166 or equivalent) during mixing and loading and gloves during cleaning of spray equipment.

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

—Common RMM:

—The following RMMs have to be considered during mixing and loading of the products:

—Manual phases should be reduced to the strict minimum;

—Regular cleaning of equipment and work area;

—Avoidance of contact with contaminated tools and objects.

—Apply the product on all the surfaces except the ceiling

—For pig breeding: For use only in animal housings, where lying areas of suckling piglets are covered with mats, strew or any other suitable material

—Do not use in breeding stations or other breeding areas for chicks.

—Do not use the product for the treatment of duck housings.

—Do not apply the product on surface which may come into contact with children.

—Do not introduce animals until a total drying.

—Do not touch or manipulate before total drying of surface.

—Do not apply the treatment in the presence of domestic animals.

—Only use in empty animal housing

—Rinse treated surfaces with drinking water after application

—Remove all food, feed and drinks prior to treatment

—Do not use in animal housings where exposure to a STP or direct emission to surface water cannot be prevented.

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

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse.

Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 and or ambulance for medical assistance.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.

If symptoms: Call 112 and or ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 and or ambulance for medical assistance.

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 nor down the drains

—Dispose of unused product, its packaging and all other waste, in accordance with local regulation

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

Shelf-life: 2 years

Keep out of reach of children and non-target animals

6. Other information

The full titles of the EN standards referenced in sections “Use-specific risk mitigation measures” are:

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

EN 14605 - Protective clothing against liquid chemicals

EN 166 – Eye protection

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

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)	KC 8000	Market area: EU
Authorisation number		EU-0029989-0003 1-3
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Chlorocresol		Active substance	59-50-7	200-431-6	24,9 % (w/w)
Propan-2-ol	Propan-2-ol	Non-active substance	67-63-0	200-661-7	12 % (w/w)
Propan-1-ol	Propan-1-ol	Non-active substance	71-23-8	200-746-9	20 % (w/w)
Salicylic acid	Salicylic acid	Non-active substance	69-72-7	200-712-3	8 % (w/w)

1. Meta spc 4 administrative information

1.1. Meta SPC 4 identifier

Identifier

Meta SPC: Meta SPC 4

1.2. Suffix to the authorisation number

Number

1-4

1.3. Product type(s)

Product type(s)

PT03: Veterinary hygiene

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 (%)
Chlorocresol		Active substance	59-50-7	200-431-6	24,9 - 24,9 % (w/w)
Propan-1-ol	Propan-1-ol	Non-active substance	71-23-8	200-746-9	23 - 23 % (w/w)
Formic acid	Formic acid	Non-active substance	64-18-6	200-579-1	11 - 11 % (w/w)

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

Formulation type(s)

SL Soluble concentrate

3. Hazard and precautionary statements of the meta spc 4

Hazard statements

H225: Highly flammable liquid and vapour.H314: Causes severe skin burns and eye damage.H317: May cause an allergic skin reaction.H335: May cause respiratory irritation.H336: May cause drowsiness or dizziness.H412: Harmful to aquatic life with long lasting effects.H290: May be corrosive to metals.

Precautionary statements

P260: Do not breathe vapours.P271: Use only outdoors or in a well-ventilated area.P272: Contaminated work clothing should not be allowed out of the workplace.P280: Wear protective gloves.P264: Wash contaminated body area thoroughly after handling.P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.P333+P313: If skin irritation or rash occurs: Get medical advice.P362+P364: Take off contaminated clothing and wash it before reuse.P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].P363: Wash contaminated clothing before reuse.P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.P310: Immediately call a POISON CENTER.P321: Specific treatment (see instructions on this label).P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.P403+P233: Store in a well-ventilated place. Keep container tightly closed.P405: Store locked up.P273: Avoid release to the environment.P501: Dispose of contents in accordance with local regulation.P234: Keep only in original packaging.P501: Dispose of container in accordance with local regulation.P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.P260: Do not breathe spray.P280: Wear protective clothing.P280: Wear eye protection.P280: Wear face protection.P333+P313: If skin irritation or rash occurs: Get medical attention.P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].P310: Immediately call a doctor.

4. Authorised use(s) of the meta spc

4.1. Use description

Table 1
Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no dataCommon name: bacteriaDevelopment stage: no dataScientific name: no dataCommon name: yeastsDevelopment stage: no dataScientific name: no dataCommon name: fungiDevelopment stage: no dataScientific name: no dataCommon name: virusesDevelopment stage: no dataScientific name: no dataCommon name: endoparasites: parasitic protozoaDevelopment stage: no dataScientific name: no dataCommon name: helminth eggsDevelopment stage: no data
Field(s) of use	indoor useVeterinary fieldConcentrated non-porous surface disinfectant for surfaces and equipment in veterinary field for poultry, pig and cattle houses
Application method(s)	Method: Automated and manual sprayingDetailed description:-
Application rate(s) and frequency	Application Rate: 250 mL/m² Dilution (%): 0,75%, 2%, 3,5% or 4% (depending on the target organism)Number and timing of application:For automated and manual spraying,Mandatory target organisms:Bacteria and yeasts: 0.75% v/v dilution of the product, 30 minutesOther target organisms:Fungi 2%v/v dilution of the product, 30 minutesEndoparasites: helminth eggs 2% v/v dilution of the product, 120 minutesFor automated spraying only,Other target organisms:Virus: 3.5% v/v dilution of the product, 30 minutesEndoparasites: parasitic protozoa” 4% v/v dilution of the product, 120 minutesFrequency: 2 to 13 times per year
Category(ies) of users	professional
Pack sizes and packaging material	1-1100 L or 1-1100 kg in HDPE container

4.1.1. Use-specific instructions for use

4.1.2. Use-specific risk mitigation measures

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

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

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

5. General directions for use of the meta spc 4

5.1. Instructions for use

—Always read the label or leaflet before use and respect all the instructions provided.

—Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).

—Precleaning of surfaces required before using disinfectants.

—Spray a recommended solution of the product within the stable on walls and floors which might come into contact with the animals (0.25 L/m²).

—Apply 250 ml/m² on the surface to be disinfected.

—Apply only on non porous surfaces.

5.2. Risk mitigation measures

—For automated spraying:

—The professional must not stay in the room during the automated application.

—Wear a respiratory protective equipment (RPE) with an assigned protection factor of at least 10 (filter type (code letter, colour) to be specified by the authorisation holder within the product information), protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information), chemical goggles in accordance with EN 166 or equivalent and protection coverall (coverall material to be specified by the authorisation holder within the product information) during mixing and loading of the product and gloves during cleaning of spray equipment.

—After disinfection of equipment, do not re-enter in room during 190 minutes.

—After disinfection of surface, do not re-enter in room during 80 minutes.

—Apply the product on all the surfaces except the ceiling

—For pig breeding: For use only in animal housings, where lying areas of suckling piglets are covered with mats, strew or any other suitable material

—Do not use in breeding stations or other breeding areas for chicks.

—Do not use the product for the treatment of duck housings.

—The following RMMs have to be considered during mixing and loading of the products:

—Manual phases should be reduced to the strict minimum;

—Regular cleaning of equipment and work area;

—Avoidance of contact with contaminated tools and objects.

—For manual spraying:

—Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information), a protective impermeable coverall (at least category III type 4, EN-14605 or equivalent) (coverall material to be specified by the authorisation holder within the product information), a respiratory protective equipment (RPE) with an assigned protection factor of at least 4 (filter type (code letter, colour) to be specified by the authorisation holder within the product information) during mixing and loading and spraying of the product, chemical goggles in accordance with EN 166 or equivalent during mixing and loading and gloves during cleaning of spray equipment

—Do not apply the product on surfaces which may come into contact with children.

—After disinfection of equipment, do not re-enter in room during 120 minutes.

—Do not introduce animals until a total drying.

—After disinfection of surface, do not re-enter in room during 45 minutes.

—Do not touch or manipulate before total drying of surface.

—Do not apply the treatment in the presence of domestic animals.

—Only use in empty animal housing.

—Rinse treated surfaces with drinking water after application

—Remove all food, feed and drinks prior to treatment.

—Do not use in animal housings where exposure to a STP or direct emission to surface water cannot be prevented.

Common RMM :

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

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse.

Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE

or a doctor.

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 and or ambulance for medical assistance.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.

If symptoms: Call 112 and or ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 and or ambulance for medical assistance.

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 nor down the drains.

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

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

Shelf-life: 2 years

Keep out of reach of children and non-target animals

6. Other information

The full titles of the EN standards referenced in sections “Use-specific risk mitigation measures” are:

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

EN 14605 - Protective clothing against liquid chemicals

EN 166 – Eye protection

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

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)	KC 9000	Market area: EU
Authorisation number		EU-0029989-0004 1-4
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Chlorocresol		Active substance	59-50-7	200-431-6	24,9 % (w/w)
Propan-1-ol	Propan-1-ol	Non-active substance	71-23-8	200-746-9	23 % (w/w)
Formic acid	Formic acid	Non-active substance	64-18-6	200-579-1	11 % (w/w)

1. Meta spc 5 administrative information

1.1. Meta SPC 5 identifier

Identifier

Meta SPC: Meta SPC 7

1.2. Suffix to the authorisation number

Number

1-5

1.3. Product type(s)

Product type(s)

PT03: Veterinary hygienePT02: Disinfectants and algaecides not intended for direct application to humans or animals

2. Meta spc 5 composition

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Chlorocresol		Active substance	59-50-7	200-431-6	4,5 - 4,5 % (w/w)
Propan-2-ol	Propan-2-ol	Non-active substance	67-63-0	200-661-7	10 - 10 % (w/w)
Pine oil	Pine oil	Non-active substance	94266-48-5	304-455-9	8 - 8 % (w/w)

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

Formulation type(s)

SL Soluble concentrate

3. Hazard and precautionary statements of the meta spc 5

Hazard statements

H315: Causes skin irritation.H317: May cause an allergic skin reaction.H318: Causes serious eye damage.H412: Harmful to aquatic life with long lasting effects.

Precautionary statements

P261: Avoid breathing vapours.P272: Contaminated work clothing should not be allowed out of the workplace.P280: Wear protective gloves.P264: Wash contaminated body area thoroughly after handling.P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.P312: Call a POISON CENTER if you feel unwell.P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.P310: Immediately call a POISON CENTER.P302+P352: IF ON SKIN: Wash with plenty of water.P333+P313: If skin irritation or rash occurs: Get medical advice.P321: Specific treatment (see instructions on this label).P362+P364: Take off contaminated clothing and wash it before reuse.P403+P233: Store in a well-ventilated place. Keep container tightly closed.P405: Store locked up.P273: Avoid release to the environment.P501: Dispose of contents in accordance with local regulation.P501: Dispose of container in accordance with local regulation.P101: If medical advice is needed, have product container or label at hand.P102: Keep out of reach of children.P103: Read carefully and follow all instructions.P261: Avoid breathing spray.P280: Wear protective clothing.P280: Wear face protection.P280: Wear eye protection.P312: Call a doctor if you feel unwell.P310: Immediately call a doctor.P333+P313: If skin irritation or rash occurs: Get medical attention.

4. Authorised use(s) of the meta spc

4.1. Use description

Table 1
Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: bacteriaCommon name: yeasts
Field(s) of use	indoor useoutdoor useVeterinary fieldConcentrated animal skin disinfectants
Application method(s)	Method: sprayingDetailed description:-
Application rate(s) and frequency	Application Rate: In order to cover the area to be disinfected Dilution (%): 8 % v/vNumber and timing of application:Mandatory target organisms:Disinfection of hoof skin with dirty conditions:Mandatory target organismsBacteria: 8% v/v, 5 minutesOther target organismsYeasts: 8% v/v, 5 minutesDisinfection of animal’s skin except feet with clean conditions:Mandatory target organisms:Bacteria and yeasts: 8% v/v, 15 minutes, 30 °CFrequency:once a week for cattle (dairy, beef, calves)once every 4 days for pigs
Category(ies) of users	professional
Pack sizes and packaging material	0,5 - 25 L container in HDPE

4.1.1. Use-specific instructions for use

—Cattle, sheep, goats and pigs on coronary band and interdigital skin of hooves when a new animal is joining the herd

—Horses on coronary band and frog when a new animal is joining the herd

—Pigs on tail and ears when a new animal is joining the herd (maximum of 30% of the herd is treated per application; once a week for cattle (dairy, beef, calves) and once every 4 days for pigs)

—Dairy cattle between the udder and the back legs before calving

—The animals should be kept standing on a clean floor for at least 15 minutes.

—The product is left to dry on skin after treatment. Precleaning of animal skin’s (except feet) is required before using disinfectants.

Apply by spraying directly on the animals’ skin for a topical disinfection:

4.1.2. Use-specific risk mitigation measures

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

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

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

4.2. Use description

Table 2
Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no dataCommon name: bacteriaDevelopment stage: no dataScientific name: no dataCommon name: yeastsDevelopment stage: no data
Field(s) of use	indoor useoutdoor useVeterinary fieldConcentrated disinfectants for non porous surfaces for examination and treatment of animals
Application method(s)	Method: sprayingDetailed description:By spraying (trigger spray only)
Application rate(s) and frequency	Application Rate: 250 mL/m² Dilution (%): 5 % v/vNumber and timing of application:Mandatory target organisms:Bacteria and yeasts 5 % v/v dilution of the product, 5 minutes, room temperatureFrequency : daily
Category(ies) of users	professional
Pack sizes and packaging material	0,5 - 25 L container in HDPE

4.2.1. Use-specific instructions for use

—Apply only on non-porous surfaces.

—Precleaning of surfaces required before using disinfectants.

4.2.2. Use-specific risk mitigation measures

—Do not (use/apply) directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food, feed, drinks and livestock/pets .The use must be restricted to applications by spray.

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

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

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

4.3. Use description

Table 3
Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no dataCommon name: bacteriaDevelopment stage: no dataScientific name: no dataCommon name: yeastsDevelopment stage: no data
Field(s) of use	indoor useVeterinary fieldConcentrated disinfectant for use on areas where pets live
Application method(s)	Method: sprayingDetailed description:By spraying (trigger spray only)
Application rate(s) and frequency	Application Rate: 250 mL/m² Dilution (%): 5 % v/vNumber and timing of application:Mandatory target organisms:Bacteria and yeasts 5% v/v dilution of the product, 15 minutesFrequency: daily
Category(ies) of users	professionalgeneral public (non-professional)
Pack sizes and packaging material	0,5 - 25 L container in HDPE

4.3.1. Use-specific instructions for use

—Comply with the instructions for use

—Apply only on non-porous surfaces.

—Precleaning of surfaces required before using disinfectants.

4.3.2. Use-specific risk mitigation measures

—Do not use directly on or near food or drinks, or on surfaces or utensils likely to be in direct contact with food and drinks

—Turn off aquarium air-filter while spraying.

—Avoid splashes and spills during pouring.

—Avoid contact with skin and eyes.

—Wash hands after use.

—For non professional, packaging has to be limited to 0,5-3 L container in HDPE and the bottles sized above 1 L and up to 3 L must be adapted with a handle and a spout.

—The packaging must be adapted with a child proof closure

—Keep pets away during treatment.

—Do not introduce animal until a total drying.

—Remove or cover terrariums, aquariums and animal cages before application.

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

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

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

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

—Keep out of reach of children and non-target animals/pets.

4.4. Use description

Table 4
Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no dataCommon name: bacteriaDevelopment stage: no dataScientific name: no dataCommon name: yeastsDevelopment stage: no data
Field(s) of use	indoor useVeterinary fieldConcentrated non porous surface disinfectant (including disinfection of animal cages by veterinarians or their assistants)
Application method(s)	Method: sprayingDetailed description:By spraying (trigger spray only)
Application rate(s) and frequency	Application Rate: 250 mL/m² Dilution (%): 5 % v/vNumber and timing of application:Mandatory target organisms:Bacteria and yeasts: 5% v/v dilution of the product, 15 minutesFrequency: daily
Category(ies) of users	professionalgeneral public (non-professional)
Pack sizes and packaging material	0,5 - 25 L container in HDPE

4.4.1. Use-specific instructions for use

—Comply with the instructions for use

—Apply only on non-porous surfaces.

—Precleaning of surfaces required before using disinfectants.

4.4.2. Use-specific risk mitigation measures

—Do not apply the treatment in the presence of livestock.

—The use must be restricted to applications by spray.

—Avoid splashes and spills during pouring.

—Avoid contact with skin and eyes.

—Wash hands after use.

—For non professional, packaging has to be limited to 0.5-3 L container in HDPE and the bottles sized above 1 L and up to 3 L must be adapted with a handle and a spout.

—The packaging must be adapted with a child proof closure

—Remove all food, feed and drinks prior to treatment.

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

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

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

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

—Keep out of reach of children and non-target animals/pets

4.5. Use description

Table 5
Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no dataCommon name: bacteriaDevelopment stage: no dataScientific name: no dataCommon name: yeastsDevelopment stage: no data
Field(s) of use	indoor useSurface disinfectionConcentrated disinfectant for non porous surfaces use in the house
Application method(s)	Method: By a mop or towelDetailed description:By a mop or towel without mechanical action
Application rate(s) and frequency	Application Rate: 250 mL/m² Dilution (%): 2,5 % v/vNumber and timing of application:Mandatory target organisms:Bacteria: 2,5% v/v dilution of the product, 15 minutes, room temperatureOther target organisms:yeasts: 2,5% v/v dilution of the product, 15 minutes, room temperatureFrequence : daily
Category(ies) of users	professional
Pack sizes and packaging material	0,5 - 25 L container in HDPE

4.5.1. Use-specific instructions for use

—Apply the diluted product with a mop or a towel. Let dry the product.

—Always test the product on a non visible part before use.

—The product cannot be used on surfaces which are in direct contact with food.

—Apply only on non-porous surfaces.

—Apply the product on a surface and then distribute with a mop or a towel.

4.5.2. Use-specific risk mitigation measures

—Do not (use/apply) directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food, feed, drinks and livestock.

—The product must be restricted to an indoor use only.

—Do not touch before total drying of surface.

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

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

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

5. General directions for use of the meta spc 5

5.1. Instructions for use

—Always read the label or leaflet before use and respect all the instructions provided.

—Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).

—Apply 250 mL/m² on the surface to be disinfected.

5.2. Risk mitigation measures

—For professionals: Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information), chemical goggles, protection coverall (coverall material to be specified by the authorisation holder within the product information) during spraying handling of product.

—The following RMMs have to be considered during handling of the products:

—Manual phases should be reduced to the strict minimum;

—Regular cleaning of equipment and work area;

—Avoidance of contact with contaminated tools and objects.

—Use only in areas inaccessible for children.

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

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

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.

Call 112 and or ambulance for medical assistance.

IF SWALLOWED:

Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 and or ambulance for medical assistance.

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor

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 nor down the drains.

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

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

Shelf-life: 2 years

6. Other information

The full titles of the EN standards referenced in sections “Use-specific risk mitigation measures” are:

EN 374 - Protective gloves against dangerous chemicals and micro-organisms

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

7. Third information level: individual products in the meta spc 5

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

Trade name(s)	Virolux 45	Market area: EU
Authorisation number		EU-0029989-0005 1-5
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Chlorocresol		Active substance	59-50-7	200-431-6	4,5 % (w/w)
Propan-2-ol	Propan-2-ol	Non-active substance	67-63-0	200-661-7	10 % (w/w)
Pine oil	Pine oil	Non-active substance	94266-48-5	304-455-9	8 % (w/w)

1. Meta spc 6 administrative information

1.1. Meta SPC 6 identifier

Identifier

Meta SPC: Meta SPC 8

1.2. Suffix to the authorisation number

Number

1-6

1.3. Product type(s)

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

2. Meta spc 6 composition

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Chlorocresol		Active substance	59-50-7	200-431-6	2,9 - 2,9 % (w/w)
Propan-2-ol	Propan-2-ol	Non-active substance	67-63-0	200-661-7	6,5 - 6,5 % (w/w)
Pine oil	Pine oil	Non-active substance	94266-48-5	304-455-9	5,2 - 5,2 % (w/w)

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

Formulation type(s)

SL Soluble concentrate

3. Hazard and precautionary statements of the meta spc 6

Hazard statements

H315: Causes skin irritation.H317: May cause an allergic skin reaction.H319: Causes serious eye irritation.H412: Harmful to aquatic life with long lasting effects.

Precautionary statements

P264: Wash contaminated body area thoroughly after handling.P272: Contaminated work clothing should not be allowed out of the workplace.P280: Wear protective gloves.P302+P352: IF ON SKIN: Wash with plenty of water.P333+P313: If skin irritation or rash occurs: Get medical advice.P362+P364: Take off contaminated clothing and wash it before reuse.P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.P337+P313: If eye irritation persists: Get medical advice.P321: Specific treatment (see Instructions on this label).P273: Avoid release to the environment.P501: Dispose of contents in accordance with local regulation.P501: Dispose of container in accordance with local regulation.P101: If medical advice is needed, have product container or label at hand.P102: Keep out of reach of children.P103: Read carefully and follow all instructions.P261: Avoid breathing vapours.P261: Avoid breathing spray.P280: Wear protective clothing.P280: Wear eye protection.P280: Wear face protection.P333+P313: If skin irritation or rash occurs: Get medical attention.P337+P313: If eye irritation persists: Get medical attention.

4. Authorised use(s) of the meta spc

4.1. Use description

Table 1
Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no dataCommon name: bacteriaDevelopment stage: no dataScientific name: no dataCommon name: yeastsDevelopment stage: no data
Field(s) of use	indoor useSurface disinfectionConcentrated disinfectant for non-porous surfaces in the house.
Application method(s)	Method: Wiping or moppingDetailed description:-
Application rate(s) and frequency	Application Rate: 250 mL/m² Dilution (%): 4 % v/vNumber and timing of application:Mandatory target organisms:Bacteria: 4% v/v dilution of the product, 15 minutes, room temperatureOther target organisms:Yeasts 4% v/v, 15 minutes, room temperatureFrequency : daily
Category(ies) of users	professional
Pack sizes and packaging material	0,5 - 2 L bottle in HDPE

4.1.1. Use-specific instructions for use

—Apply the diluted product with a mop or a towel. Let the product dry.

—Always test the product on a non visible part before use.

—The product cannot be used on surfaces which are indirect contact with food.

—Apply only on non-porous surfaces.

—Apply the product on a surface and then distribute with a mop or a towel.

—Apply 250 mL/m² on the surface to be disinfected.

4.1.2. Use-specific risk mitigation measures

—The product must be restricted to an indoor use only.

—For professionals, the following RMMs have to be considered during the handling of the products :

—Manual phases should be reduced to the strict minimum;

—Regular cleaning of equipment and work area;

—Avoidance of contact with contaminated tools and objects.

—Use only in areas inaccessible for children

—Do not touch before total drying of surface.

—For professionals: Wear protective chemical resistant glovesmeeting the requirements of European Standard EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information) and protection coverall (coverall material to be specified by the authorisation holder within the product informatione) during manipulation of the product.

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work

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

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

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

4.2. Use description

Table 2
Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no dataCommon name: bacteriaDevelopment stage: no dataScientific name: no dataCommon name: yeastsDevelopment stage: no data
Field(s) of use	indoor useToilet bowl disinfectionConcentrated disinfectant for toilet bowls
Application method(s)	Method: By pouringDetailed description:-
Application rate(s) and frequency	Application Rate: 30 mL of product in the toilet bowl - ready to useNumber and timing of application:Mandatory target organisms:Bacteria: 15 minutes, room temperatureOther target organisms:Yeasts: 15 minutes, room temperatureFrequency: once a day
Category(ies) of users	general public (non-professional)
Pack sizes and packaging material	0,5 - 3 L container in HDPE for non-professionals

4.2.1. Use-specific instructions for use

—Comply with the instructions for use

—Apply only on non-porous surfaces.

—Apply the product pure under the rim with the toilet duck and follow once the complete circle of the toilet.

4.2.2. Use-specific risk mitigation measures

—The packaging should have a goose neck and must be adapted with a child proof closure

—Pour the liquid very close to the bucket/toilet to avoid projections.

—Avoid splashes and spills during pouring.

—Avoid contact with skin and eyes.

—Wash hands after use.

—Use the product only once a day

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

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

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

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

—Keep out of reach of children and non-target animals/pets.

5. General directions for use of the meta spc 6

5.1. Instructions for use

—Always read the label or leaflet before use and respect all the instructions provided.

—Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).

—The authorisation holder should give indications of application of the product (dilution, quantity applied on surface, etc …) on the label in order to guarantee the safe and efficient use of the product during its application. The volume of product to be diluted and the specified volume of water should be clearly indicated on the label.

5.2. Risk mitigation measures

—Do not (use and or apply) directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food, feed, drinks and livestock .

—Do not apply the product on surface in contact with children.

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

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF IN EYES: IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 and or ambulance for medical assistance.

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

7. Third information level: individual products in the meta spc 6

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

Trade name(s)	Virolux 30	Market area: EU
Authorisation number		EU-0029989-0006 1-6
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Chlorocresol		Active substance	59-50-7	200-431-6	2,9 % (w/w)
Propan-2-ol	Propan-2-ol	Non-active substance	67-63-0	200-661-7	6,5 % (w/w)
Pine oil	Pine oil	Non-active substance	94266-48-5	304-455-9	5,2 % (w/w)