LegalizeCommission Implementing Regulation (EU) 2023/2747 of 8 December 2023 amending Implementing Regulation (EU) 2022/1391 granting a Union authorisation for the biocidal product family Lactic acid based products – CID Lines NV in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
see general directions for use for Meta SPC 13
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 13
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions for use for Meta SPC 13
5. GENERAL DIRECTIONS FOR USE 16
OF THE META SPC 13
5.1. Instructions for use
The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection.
The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.
Products must be diluted in potable water before use.
5.2. Risk mitigation measures
Gloves and goggles are needed during mixing and loading.
Wear protective coverall (to be specified by the authorisation holder within the product information).
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
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. 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
5.4. Instructions for safe disposal of the product and its packaging
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.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
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.
6. OTHER INFORMATION
/
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 13
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Tornax L | Tornax L | Market area: EU | Market area: EU | Market area: EU |
| Lacto Cid | Lacto Cid | Market area: EU | Market area: EU | Market area: EU | |
| Authorisation number | EU-0027740-0016 1-13 | EU-0027740-0016 1-13 | EU-0027740-0016 1-13 | EU-0027740-0016 1-13 | EU-0027740-0016 1-13 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 11,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 4,5 |
| Methanesulfonic acid | Methanesulfonic acid | Non-active substance | 75-75-2 | 200-898-6 | 10,5 |
META SPC 14
1. META SPC 14 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 14 identifier
| Identifier | Meta SPC 14: Ready to use hygienic handrub (PT1) |
1.2. Suffix to the authorisation number
| Number | 1-14 |
1.3. Product type(s)
| Product type(s) | PT01 – Human hygiene (Disinfectants) |
2. META SPC 14 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 14
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 3,6 | 3,6 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 2,0 | 2,0 |
| Isopropanol | Propan-2-ol | Non-active substance | 67-63-0 | 200-661-7 | 4,0 | 4,0 |
| Butyldiglycol | 2-(2-butoxyethoxy)ethanol | Non-active substance | 112-34-5 | 203-961-6 | 10,0 | 10,0 |
2.2. Type(s) of formulation of the meta SPC 14
| Formulation(s) | AL – Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 14
| Hazard statements | Causes serious eye damage. |
| Precautionary statements | Wear eye/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. |
4. AUTHORISED USE(S) OF THE META SPC 14
4.1. Use description
Table 29
Use # 1 – Hygienic handrub, for professional use (PT1)
| 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 in Food/feed industry; Public field; Kitchens Hygienic handrub, on visibly clean hands |
| Application method(s) | Method: By rubbing the hands Detailed description: / |
| Application rate(s) and frequency | Application Rate: 6 mL of product Dilution (%): - Number and timing of application: Active against bacteria and yeasts: RTU (with 3,6 % Lactic acid) 6 mL (that is three pushes for both hands together) One minute contact time |
| 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) |
4.1.1. Use-specific instructions for use
see general directions for use for Meta SPC 14
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
see general directions for use for Meta SPC 14
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 14
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions for use for Meta SPC 14
5. GENERAL DIRECTIONS FOR USE 17
OF THE META SPC 14
5.1. Instructions for use
Apply 6 ml of the product undiluted. Respect a contact time of 1 minute. Rinse thoroughly after disinfection.
For professional use only
5.2. Risk mitigation measures
/
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 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
5.4. Instructions for safe disposal of the product and its packaging
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.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
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.
6. OTHER INFORMATION
/
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 14
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Kenosan Hand Rub | Kenosan Hand Rub | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | EU-0027740-0017 1-14 | EU-0027740-0017 1-14 | EU-0027740-0017 1-14 | EU-0027740-0017 1-14 | EU-0027740-0017 1-14 |
| 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 | 2,0 |
| Isopropanol | Propan-2-ol | Non-active substance | 67-63-0 | 200-661-7 | 4,0 |
| Butyldiglycol | 2-(2-butoxyethoxy)ethanol | Non-active substance | 112-34-5 | 203-961-6 | 10,0 |
’
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 10.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 11.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 12.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 13.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 14.
ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj
ISSN 1977-0677 (electronic edition)
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