LegalizeCommission Implementing Regulation (EU) 2022/1391 of 26 July 2022 granting a Union authorisation for the biocidal product family ‘Lactic acid based products – CID Lines NV’ (Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0027740-0000 is granted to CID Lines NV for the making available on the market and use of the biocidal product family ‘Lactic acid based products – CID Lines NV’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.
The Union Authorisation is valid from 1 September 2022 to 31 August 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.
ANNEX I
TERMS AND CONDITIONS (EU-0027740-0000)
The authorisation holder shall conduct a long-term storage stability test at ambient temperature of ‘Lactic acid based products – CID Lines NV’ in commercial packaging in which the products in the family will be made available on the market. All relevant properties should be determined prior and after storage.
By 1 March 2023 the authorisation holder shall submit the results of the test to the Agency.
ANNEX II
Lactic acid based products – CID LINES NV
Product type 1 – Human hygiene (Disinfectants)
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-0027740-0000
R4BP asset number: EU-0027740-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
| Name | Lactic acid based products – CID LINES NV |
|---|---|
| Product type(s) | PT01 – Human hygiene (Disinfectants) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 – Veterinary hygiene (Disinfectants) PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Waterpoortstraat 2, 8900 Ieper Belgium |
| Authorisation number | EU-0027740-0000 |
| R4BP asset number | EU-0027740-0000 |
| Date of the authorisation | 31 December 2023 |
| Expiry date of the authorisation | 31 August 2032 |
| Name of manufacturer | CID LINES NV |
| --- | --- |
| Address of manufacturer | Waterpoortstraat 2, 8900 Ieper Belgium |
| Location of manufacturing sites | Waterpoortstraat 2, 8900 Ieper Belgium |
| Active substance | L-(+)-lactic acid |
| --- | --- |
| Name of manufacturer | Purac Biochem bv |
| Address of manufacturer | Arkelsedijk 46, 4206 Gorinchem Netherlands |
| Location of manufacturing sites | Arkelsedijk 46, 4206 Gorinchem Netherlands |
| Active substance | L-(+)-lactic acid |
| --- | --- |
| Name of manufacturer | Jungbunzlauer S.A. |
| Address of manufacturer | Z.I. et Portuaire, B.P. 32, 67390 Marckolsheim France |
| Location of manufacturing sites | Z.I. et Portuaire, B.P. 32, 67390 Marckolsheim France |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | |
|---|---|---|---|---|---|---|
| Min | Max | |||||
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 2,0 | 70,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 0,0 | 12,0 |
| Sodium lauryl ether sulfate | Alcohols, C12-14, ethoxylated, sulfates, sodium salts | Non-active substance | 68891-38-3 | 500-234-8 | 0,0 | 8,4 |
| Sulfonic acids, C14-17-sec-alkane, sodium salts | Sulfonic acids, C14-17-sec-alkane, sodium salts | Non-active substance | 97489-15-1 | 307-055-2 | 0,0 | 2,25 |
| C6 alkyl glucoside | Hexyl D-Glucoside | Non-active substance | 54549-24-5 | 259-217-6 | 0,0 | 2,4 |
| Isopropanol | Propan-2-ol | Non-active substance | 67-63-0 | 200-661-7 | 0,0 | 5,0 |
| Methanesulfonic acid | Methanesulfonic acid | Non-active substance | 75-75-2 | 200-898-6 | 0,0 | 19,5 |
| Sulphuric acid | Sulphuric acid | Non-active substance | 7664-93-9 | 231-639-5 | 0,0 | 10,5 |
| Butyldiglycol | 2-(2-butoxyethoxy)ethanol | Non-active substance | 112-34-5 | 203-961-6 | 0,0 | 10,0 |
| Formulation(s) | AL – Any other liquid SL – Soluble concentrate WI – Wipes | |||||
| --- | --- |
PART II
SECOND INFORMATION LEVEL – META SPC(S)
META SPC 1
| Identifier | Meta SPC 1: Ready to use hygienic handwash (PT1) |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT01 – Human hygiene (Disinfectants) |
| --- | --- |
| Common name | IUPAC name |
| --- | --- |
| Min | Max |
| L-(+)-lactic acid | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts |
| Isopropanol | Propan-2-ol |
| Formulation(s) | AL – Any other liquid |
| --- | --- |
| Hazard statements | Causes serious eye damage. |
| --- | --- |
| Precautionary statements | Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. |
| Product type | PT01 – Human hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Other: Bacteria Common name: Bacteria Development stage: Scientific name: Other: Yeast Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Food and feed industry, Public field and Kitchens: Hygienic handwash |
| Application method(s) | Method: - Detailed description: - |
| Application rate(s) and frequency | Application Rate: 10 mL of undiluted product (that is four pushes for both hands together) Dilution (%): - Number and timing of application: Apply 10 mL of undiluted product (that is four pushes for both hands together) and wash your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 50 mL, 75 mL, 100 mL, 150 mL, 500 mL, 1L, 5L, 10L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L HDPE (High Density Polyethylene) |
see general directions for use for Meta SPC 1
/
see general directions for Meta SPC 1
see general directions for Meta SPC 1
see general directions for Meta SPC 1
Wet your hands with clean, running water at room temperature
Turn off the tap
Apply 10 mL of undiluted product and rub your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry.
For professional use only
/
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 INHALED: If symptoms occur 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. Immediately call 112/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/ambulance for medical assistance.
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
/
| Trade name(s) | Kenosan Hand Scrub | Market area: EU | |||
|---|---|---|---|---|---|
| Authorisation number | EU-0027740-0001 1-1 | ||||
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 3,6 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 5,0 |
| Isopropanol | Propan-2-ol | Non-active substance | 67-63-0 | 200-661-7 | 4,0 |
META SPC 2
| Identifier | Meta SPC 2: Ready to use Algaecide |
|---|---|
| Number | 1-2 |
| --- | --- |
| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Common name | IUPAC name |
| --- | --- |
| Min | Max |
| L-(+)-lactic acid | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts |
| Formulation(s) | AL – Any other liquid |
| --- | --- |
| Hazard statements | Causes serious eye irritation. |
| --- | --- |
| Precautionary statements | If medical advice is needed, have product container or label at hand. Keep out of reach of children. Read carefully and follow all instructions. Wash hands thoroughly after handling. Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. If skin irritation occurs:Get medical advice. If eye irritation persists:Get medical advice. Take off contaminated clothing.And wash it before reuse. |
| 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) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Scientific name: unicellular green algae and blue-green algae Common name: cyanobacteria Development stage: |
| Field(s) of use | Indoor Outdoor Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning. |
| Application method(s) | Method: By brushing, by spraying (low pressure) or pouring Detailed description: / |
| Application rate(s) and frequency | Application Rate: 100 mL/m2 Dilution (%): - Number and timing of application: Active against bacteria, yeasts and unicellular green algae and blue-green algae (cyanobacteria): With undiluted product at 20 – 25 °C In 3h contact time 100 mL/m2 The biocidal product is not intended to be used on surfaces that come into contact with food and feed. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg HDPE (High Density Polyethylene) |
see general directions for use for Meta SPC 2
/
see general directions for use for Meta SPC 2
see general directions for use for Meta SPC 2
see general directions for use for Meta SPC 2
| 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) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Scientific name: unicellular green algae and blue-green algae Common name: Cyanobacteria Development stage: |
| Field(s) of use | Indoor Outdoor Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning. |
| Application method(s) | Method: By brushing, by spraying (low pressure) or pouring Detailed description: / |
| Application rate(s) and frequency | Application Rate: 100 mL/m2 Dilution (%): - Number and timing of application: Active against bacteria, yeasts and unicellular green algae and blue-green algae (cyanobacteria): With undiluted product at 20 – 25 °C In 3h contact time 100 mL/m2 The biocidal product is not intended to be used on surfaces that come into contact with food and feed. |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | 1 L, 5 L, 10 L 1 kg, 5 kg, 10 kg HDPE (High Density Polyethylene) |
see general directions for use for Meta SPC 2
/
see general directions for use for Meta SPC 2
see general directions for use for Meta SPC 2
see general directions for use for Meta SPC 2
Comply with the instructions for use
The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: ‘Make sure to wet surfaces completely’.
The required contact time has to be respected until further treatments (for example brushing the surfaces).
Use 100 mL solution/m2
/
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for five 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/ambulance for medical assistance.
If medical advice is needed, have product container or label at hand
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
Keep out of reach of children and non-target animals/pets.
/
| Trade name(s) | RTU Algaecide | Market area: EU | |||
|---|---|---|---|---|---|
| Authorisation number | EU-0027740-0002 1-2 | ||||
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 2,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 0,6 |
META SPC 3
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