LegalizeCommission Implementing Regulation (EU) 2023/1311 of 27 June 2023 granting a Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0028957-0000 is hereby granted to CVAS Development GmbH for the making available on the market and use of the biocidal product family ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 18 July 2023 to 30 June 2033.
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
CVAS Biocidal Product Family based on L(+) Lactic Acid
Product type(s)
PT03: Veterinary hygiene
PT04: Food and feed area
Authorisation number EU-0028957-0000
R4BP asset number EU-0028957-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
| Name | CVAS Biocidal Product Family based on L(+) Lactic Acid |
|---|---|
| Product type(s) | PT03: Veterinary hygiene PT04: Food and feed area |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Am Hafen 16 68526 Ladenburg DE |
| Authorisation number | |
| R4BP asset number | |
| Date of the authorisation | |
| Expiry date of the authorisation | |
| Name of manufacturer | Calvatis GmbH |
| --- | --- |
| Address of manufacturer | Am Hafen 16 68526 Ladenburg Germany |
| Location of manufacturing sites | Calvatis GmbH site 1 Am Hafen 16 68526 Ladenburg Germany |
| Name of manufacturer | Arthur Schopf Hygiene GmbH & Co. KG |
| --- | --- |
| Address of manufacturer | Pfaffensteinstraße 1 83115 Neubeuern Germany |
| Location of manufacturing sites | Arthur Schopf Hygiene GmbH & Co. KG site 1 Pfaffensteinstraße 1 83115 Neubeuern Germany |
| Active substance | L-(+)-lactic acid |
| --- | --- |
| Name of manufacturer | Purac Biochem bv |
| Address of manufacturer | Arkelsedijk 46 4206AC Gorinchem Netherlands (the) |
| Location of manufacturing sites | Purac Biochem bv site 1 Arkelsedijk 46 4206AC Gorinchem Netherlands (the) |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 1,92 - 17,6 % (w/w) | |
| Methanesulphonic acid | Methanesulphonic acid | Non-Active substance | 75-75-2 | 200-898-6 | 0 - 10,5 % (w/w) |
| Phosphoric acid | Phosphoric acid | Non-Active substance | 7664-38-2 | 231-633-2 | 0 - 18,75 % (w/w) |
| Sulphuric acid | Sulphuric acid | Non-Active substance | 7664-93-9 | 231-639-5 | 0 - 4,5 % (w/w) |
| Isononanoic acid | Isononanoic acid | Non-Active substance | 3302-10-1 | 221-975-0 | 0 - 2,5 % (w/w) |
| Formulation type(s) | AL Any other liquid SL Soluble concentrate | ||||
| --- | --- |
PART II
SECOND INFORMATION LEVEL - META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
| Identifier | Meta SPC: mSPC1 |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT03: Veterinary hygiene |
| --- | --- |
2. META SPC 1 COMPOSITION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 1,92 - 1,96 % (w/w) | |
| Formulation type(s) | AL Any other liquid | ||||
| --- | --- |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | |
|---|---|
| Precautionary statements |
4. AUTHORISED USE(S) OF THE META SPC
| Product type | PT03: Veterinary hygiene |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data |
| Field(s) of use | indoor use Teat-disinfection post-milking |
| Application method(s) | Method: Dipping Detailed description: Teat-disinfection post-milkingManual dipping using a dip cupAutomated dipping by robot |
| Application rate(s) and frequency | Application rate: Ready-To-Use (RTU) product, 1,92-1,96% L-(+)-lactic acid - Number and timing of application: 2-3 times a day (after each milking) |
| Category(ies) of users | professional |
| Pack sizes and packaging material | High density polyethylene (HDPE) jerrycan: 5-60 kg HDPE drum: 60-200 kg HDPE Intermediate Bulk Container (IBC): 600-1000 kg |
See general directions for use.
See general directions for use.
See general directions for use.
See general directions for use.
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
None
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: if symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.
IF SWALLOWED: if symptoms occur call a POISON CENTRE or a doctor.
Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like
sawdust. Dispose of the material collected in accordance with local regulations.
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
6. OTHER INFORMATION
Not relevant
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
| Trade name(s) | calgodip Amadine Film | Market area: EU | |||
|---|---|---|---|---|---|
| AGRIMARKT MILCHSÄUREMANTEL | Market area: EU | ||||
| IWETEC MILCHSÄURE DIPP | Market area: EU | ||||
| Fulldip Lacti Film | Market area: EU | ||||
| CareDip Film | Market area: EU | ||||
| Milchsäure Film | Market area: EU | ||||
| Lactoboost Film | Market area: EU | ||||
| Bonimal CARE Lac Dip | Market area: EU | ||||
| Bonimal CARE LactiVital Dip | Market area: EU | ||||
| Impos Filmdipp M | Market area: EU | ||||
| Melkpower Filmdipp M | Market area: EU | ||||
| Authorisation number | EU-0028957-0001 1-1 | ||||
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 1,92 % (w/w) | |
| Trade name(s) | Dip es lac DL | Market area: EU | |||
| --- | --- | --- | --- | --- | --- |
| Traylac O-F | Market area: EU | ||||
| Baktostop Lactic | Market area: EU | ||||
| Lacti-Bac Dip | Market area: EU | ||||
| DS 1.0 F | Market area: EU | ||||
| Authorisation number | EU-0028957-0002 1-1 | ||||
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 1,92 % (w/w) | |
| Trade name(s) | calgodip Blue Kamille Film | Market area: EU | |||
| --- | --- | --- | --- | --- | --- |
| HappyFarm KamillDip Film | Market area: EU | ||||
| Lacto Film | Market area: EU | ||||
| MS Film | Market area: EU | ||||
| LA Film | Market area: EU | ||||
| BestFarm Blue Dip Film | Market area: EU | ||||
| Bonimal CARE Milky Dip | Market area: EU | ||||
| Bonimal CARE Milki Dip | Market area: EU | ||||
| Bonimal CARE Milk Dip | Market area: EU | ||||
| PQ-Blue Film | Market area: EU | ||||
| Dipp Top | Market area: EU | ||||
| Authorisation number | EU-0028957-0003 1-1 | ||||
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 1,92 % (w/w) | |
| Trade name(s) | Dip es protect DL | Market area: EU | |||
| --- | --- | --- | --- | --- | --- |
| BaktoStop lactic H | Market area: EU | ||||
| Dip Agro Protect | Market area: EU | ||||
| Kuhmilin Dip Top M | Market area: EU | ||||
| Lacti-Protect Dip | Market area: EU | ||||
| DSR 1.5 F | Market area: EU | ||||
| ProfiMix inSilk | Market area: EU | ||||
| Authorisation number | EU-0028957-0004 1-1 | ||||
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 1,92 % (w/w) |
1. META SPC 2 ADMINISTRATIVE INFORMATION
| Identifier | Meta SPC: mSPC2 |
|---|---|
| Number | 1-2 |
| --- | --- |
| Product type(s) | PT03: Veterinary hygiene |
| --- | --- |
2. META SPC 2 COMPOSITION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 6,8 - 6,8 % (w/w) | |
| Formulation type(s) | AL Any other liquid | ||||
| --- | --- |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
| Hazard statements | H315: Causes skin irritation. H318: Causes serious eye damage. |
|---|---|
| Precautionary statements | P264: Wash hands thoroughly after handling. P280: Wear protective gloves. P280: Wear eye protection. P302+P352: IF ON SKIN: Wash with plenty of water. P332+P313: If skin irritation occurs: Get medical advice. P332+P313: If skin irritation occurs: Get medical attention. 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. P310: Immediately call a doctor. P501: Dispose of contents to in accordance with local regulations. P501: Dispose of container to in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
| Product type | PT03: Veterinary hygiene |
|---|---|
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data |
| Field(s) of use | indoor use Teat-disinfection post-milking |
| Application method(s) | Method: Dipping Detailed description: Teat-disinfection post-milkingManual dipping using a dip cupAutomated dipping by robot |
| Application rate(s) and frequency | Application rate: RTU product, 6,80% L-(+)-lactic acid - Number and timing of application: 2-3 times a day (after each milking) |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE jerrycan: 5-60 kg HDPE drum: 60-200 kg HDPE IBC: 600-1000 kg |
See general directions for use.
See general directions for use.
See general directions for use.
See general directions for use.
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
The product must be brought to a temperature between 20°C and 30°C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.
Apply the product by manual or automated dipping. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.
Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.
After disinfection clean the application equipment by rinsing with water.
Keep out of reach of children.
Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent. See section 6 for the full titles of the EN standards.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
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. See section 6 for the full reference to this act.
IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.
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 or an 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 or an ambulance for medical assistance.
Environmental precautions: do not allow product to reach sewage systems or water bodies.
Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like sawdust. Dispose of the material collected in accordance with local regulations.
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.
Shelf life: 24 months
Do not store at temperatures above 40°C.
Keep away from heat and direct sunlight.
Protect from frost.
Keep container tightly closed.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.