LegalizeCommission Implementing Regulation (EU) 2025/523 of 20 March 2025 amending Implementing Regulation (EU) 2023/1311 as regards administrative changes to the Union authorisation for the biocidal product family CVAS Biocidal Product Family based on L(+) Lactic Acid
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.
| Image omitted; see official source | Official Journal of the European Union | EN L series |
| --- | --- | --- |
| 2025/523 | 21.3.2025 |
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products 1, and in particular Article 50(2) thereof,
Whereas:
- (1) On 27 June 2023, Commission Implementing Regulation (EU) 2023/1311 2 granted a Union authorisation, under number EU-0028957-0000, 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’. The Annex to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for that biocidal product family.
- (2) On 12 September 2023 and 4 July 2024, CVAS Development GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 3, notifications of administrative changes to the Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’, recorded in the register for biocidal products under case numbers BC-XW088611-94 and BC-PQ098457-00. The notified proposed changes concern the addition of trade names.
- (3) On 13 October 2023 and 2 August 2024 4, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions on the notified administrative changes to the Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’. In the opinions, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.
- (4) On 26 July 2024, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’ in all official languages of the Union, covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.
- (5) The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’ to introduce the administrative changes requested by CVAS Development GmbH.
- (6) Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’ as set out in Annex to Implementing Regulation (EU) 2023/1311 remain unchanged.
- (7) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2023/1311 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the register for biocidal products in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes.
- (8) Implementing Regulation (EU) No 2023/1311 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Implementing Regulation (EU) 2023/1311 is replaced by the text set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 March 2025.
For the Commission
The President
Ursula VON DER LEYEN
Commission 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 (OJ L 162, 28.6.2023, p. 11, ELI: http://data.europa.eu/eli/reg_impl/2023/1311/oj).
Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).
ECHA opinions UAD-C-1688636-18-00/F of 13 October 2023 and UAD-C-1756814-27-00/F of 2/08/2024 on administrative changes of the Union authorisation of the biocidal product family ‘CVAS Biocidal Product Family based on L(+) Lactic Acid’, https://echa.europa.eu/opinions-on-union-authorisation.
ANNEX
Summary of product characteristics for a biocidal product family
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
1.1. Family name
| Name | CVAS Biocidal Product Family based on L(+) Lactic Acid |
1.2. Product type(s)
| Product type(s) | PT03: Veterinary hygiene PT04: Food and feed area |
1.3. Authorisation holder
| Name and address of the authorisation holder | Name | CVAS Development GmbH |
| Name and address of the authorisation holder | Address | Am Hafen 16 68526 Ladenburg DE |
| Authorisation number | EU-0028957-0000 | |
| R4BP asset number | EU-0028957-0000 | |
| Date of the authorisation | 18.7.2023 | |
| Expiry date of the authorisation | 30.6.2033 |
1.4. Manufacturer(s) of the product
| 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 |
1.5. Manufacturer(s) of the active substance(s)
| 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
2.1. Qualitative and quantitative information on the composition of the family
| 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) |
2.2. Type(s) of formulation
| Formulation type(s) | AL Any other liquid 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: mSPC1 |
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 (%) |
|---|---|---|---|---|---|
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 1,92 - 1,96 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 1
| 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
4.1. Use description
Table 1
Use # 1.1 – Teat-disinfection post-milking by manual or automated dipping
| 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 |
4.1.1. Use-specific instructions
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use
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.
5.2. Risk mitigation measures
None
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
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.
Emergency measure to protect the environment
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.
5.4. Instructions for safe disposal of the product and its packaging
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.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
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
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | calgodip Amadine Film | calgodip Amadine Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | AGRIMARKT MILCHSÄUREMANTEL | AGRIMARKT MILCHSÄUREMANTEL | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | IWETEC MILCHSÄURE DIPP | IWETEC MILCHSÄURE DIPP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Fulldip Lacti Film | Fulldip Lacti Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | CareDip Film | CareDip Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Milchsäure Film | Milchsäure Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Lactoboost Film | Lactoboost Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Bonimal CARE Lac Dip | Bonimal CARE Lac Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Bonimal CARE LactiVital Dip | Bonimal CARE LactiVital Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Impos Filmdipp M | Impos Filmdipp M | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Melkpower Filmdipp M | Melkpower Filmdipp M | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | EU-0028957-0001 1-1 | EU-0028957-0001 1-1 | |||
| Common name | IUPAC name | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 1,92 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Dip es lac DL | Dip es lac DL | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Traylac O-F | Traylac O-F | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Baktostop Lactic | Baktostop Lactic | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Lacti-Bac Dip | Lacti-Bac Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | DS 1.0 F | DS 1.0 F | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | EU-0028957-0002 1-1 | EU-0028957-0002 1-1 | |||
| Common name | IUPAC name | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 1,92 % (w/w) |
7.3. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | calgodip Blue Kamille Film | calgodip Blue Kamille Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HappyFarm KamillDip Film | HappyFarm KamillDip Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Lacto Film | Lacto Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | MS Film | MS Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | LA Film | LA Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | BestFarm Blue Dip Film | BestFarm Blue Dip Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bonimal CARE Milky Dip | Bonimal CARE Milky Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bonimal CARE Milki Dip | Bonimal CARE Milki Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bonimal CARE Milk Dip | Bonimal CARE Milk Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PQ-Blue Film | PQ-Blue Film | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Dipp Top | Dipp Top | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0003 1-1 | EU-0028957-0003 1-1 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 1,92 % (w/w) |
7.4. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Dip es protect DL | Dip es protect DL | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | BaktoStop lactic H | BaktoStop lactic H | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Dip Agro Protect | Dip Agro Protect | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Kuhmilin Dip Top M | Kuhmilin Dip Top M | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Lacti-Protect Dip | Lacti-Protect Dip | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | DSR 1.5 F | DSR 1.5 F | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ProfiMix inSilk | ProfiMix inSilk | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0004 1-1 | EU-0028957-0004 1-1 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 1,92 % (w/w) |
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
| Identifier | Meta SPC: mSPC2 |
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 (%) |
|---|---|---|---|---|---|
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 6,8 - 6,8 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 2
| 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
4.1. Use description
Table 1
Use # 2.1 – Teat-disinfection post-milking by manual or automated dipping
| 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 |
4.1.1. Use-specific instructions
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use
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.
5.2. Risk mitigation measures
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.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
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.
Emergency measure to protect the environment
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.
5.4. Instructions for safe disposal of the product and its packaging
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.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
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
The full titles of EN standards mentioned in the section 5.2 ‘Risk mitigation measures’ are:
EN ISO 16321– Eye and face protection for occupational users.
EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms.
The full reference of the legal act mentioned in the section 5.2 ‘Risk mitigation measures’ is:
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).
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) | Trade name(s) | Trade name(s) | calgodip Amadine forte Film | calgodip Amadine forte Film | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0005 1-2 | EU-0028957-0005 1-2 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 6,8 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Dip es lac DLX | Dip es lac DLX | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0006 1-2 | EU-0028957-0006 1-2 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 6,8 % (w/w) |
7.3. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | calgodip Blue Kamille forte Film | calgodip Blue Kamille forte Film | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0007 1-2 | EU-0028957-0007 1-2 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 6,8 % (w/w) |
7.4. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Dip es protect DLX | Dip es protect DLX | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0008 1-2 | EU-0028957-0008 1-2 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 6,8 % (w/w) |
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
| Identifier | Meta SPC: mSPC3 |
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 (%) |
|---|---|---|---|---|---|
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 1,92 - 1,96 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 3
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
| Hazard statements | |
| Precautionary statements |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use # 3.1 – Teat-disinfection post-milking by manual or automated dipping or spraying
| 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 Method: Spraying Detailed description: Teat-disinfection post-milkingManual spraying using a trigger sprayerManual spraying using an electronic sprayerAutomated spraying by robot |
| Application rate(s) and frequency | Application rate: RTU product, 1,92-1,96% L-(+)-lactic acid - Number and timing of application: 2-3 times a day (after each milking) Application rate: 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 | HDPE jerrycan: 5-60 kg HDPE drum: 60-200 kg HDPE IBC: 600-1000 kg |
4.1.1. Use-specific instructions
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1. Instructions for use
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 or spraying. 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.
5.2. Risk mitigation measures
None
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
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.
Emergency measure to protect the environment
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.
5.4. Instructions for safe disposal of the product and its packaging
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.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
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 3
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | calgodip Amadine Spray | calgodip Amadine Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | AGRIMARKT MILCHSÄURENEBEL | AGRIMARKT MILCHSÄURENEBEL | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IWETEC MILCHSÄURE SPRAY | IWETEC MILCHSÄURE SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Fulldip Lacti Spray | Fulldip Lacti Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | CareDip Spray | CareDip Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Milchsäure Spray | Milchsäure Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Lactoboost Spray | Lactoboost Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Care4cows Lactic Acid Spray | Care4cows Lactic Acid Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bonimal CARE Lac Spray | Bonimal CARE Lac Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bonimal CARE LactiVital Spray | Bonimal CARE LactiVital Spray | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0009 1-3 | EU-0028957-0009 1-3 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 1,92 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Dip es lac DL Spray | Dip es lac DL Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Traylac O-S | Traylac O-S | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Lacti-Bac Spray | Lacti-Bac Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | DS 1.0 S | DS 1.0 S | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0010 1-3 | EU-0028957-0010 1-3 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 1,92 % (w/w) |
7.3. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | calgodip Blue Kamille Spray | calgodip Blue Kamille Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HappyFarm KamillDip Spray | HappyFarm KamillDip Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Lacto Spray | Lacto Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | MS Spray | MS Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | LA Spray | LA Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Care4Cows Lactic Acid Kamille Spray | Care4Cows Lactic Acid Kamille Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | BestFarm Blue Dip Spray | BestFarm Blue Dip Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bonimal CARE Milky Spray | Bonimal CARE Milky Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bonimal CARE Milki Spray | Bonimal CARE Milki Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bonimal CARE Milk Spray | Bonimal CARE Milk Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PQ-Blue Spray | PQ-Blue Spray | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0011 1-3 | EU-0028957-0011 1-3 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 1,92 % (w/w) |
7.4. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Dip es protect DL Spray | Dip es protect DL Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Dip Agro Protect SP | Dip Agro Protect SP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Kuhmilin Sprüh Top M | Kuhmilin Sprüh Top M | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Lacti-Protect Spray | Lacti-Protect Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | DSR 1.5 S | DSR 1.5 S | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0012 1-3 | EU-0028957-0012 1-3 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 1,92 % (w/w) |
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
| Identifier | Meta SPC: mSPC4 |
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 (%) |
|---|---|---|---|---|---|
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 6,8 - 6,8 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 4
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
| 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
4.1. Use description
Table 1
Use # 4.1 – Teat-disinfection post-milking by manual or automated dipping or spraying
| 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 Method: Spraying Detailed description: Teat-disinfection post-milkingManual spraying using a trigger sprayerManual spraying using an electronic sprayerAutomated spraying 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) 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 |
4.1.1. Use-specific instructions
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
5.1. Instructions for use
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 or spraying. 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.
5.2. Risk mitigation measures
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.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of 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
First aid instructions
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.
Emergency measure to protect the environment
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.
5.4. Instructions for safe disposal of the product and its packaging
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.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
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 4
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | calgodip Amadine forte Spray | calgodip Amadine forte Spray | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0013 1-4 | EU-0028957-0013 1-4 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 6,8 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Dip es lac DLX Spray | Dip es lac DLX Spray | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0014 1-4 | EU-0028957-0014 1-4 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 6,8 % (w/w) |
7.3. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | calgodip Blue Kamille forte Spray | calgodip Blue Kamille forte Spray | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0015 1-4 | EU-0028957-0015 1-4 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 6,8 % (w/w) |
7.4. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Dip es protect DLX Spray | Dip es protect DLX Spray | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0016 1-4 | EU-0028957-0016 1-4 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 6,8 % (w/w) |
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 5 identifier
| Identifier | Meta SPC: mSPC5 |
1.2. Suffix to the authorisation number
| Number | 1-5 |
1.3. Product type(s)
| Product type(s) | PT03: Veterinary hygiene |
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 (%) |
|---|---|---|---|---|---|
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 1,92 - 1,96 %(w/w) |
2.2. Type(s) of formulation of the meta SPC 5
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
| Hazard statements | H315: Causes skin irritation. H319: Causes serious eye irritation. |
| 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. P337+P313: If eye irritation persists: Get medical advice. P337+P313: If eye irritation persists: Get medical attention. P501: Dispose of container to in accordance with local regulations. P501: Dispose of contents to in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use # 5.1 – Teat-disinfection post-milking by manual or automated dipping or spraying
| 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 Method: Spraying Detailed description: Teat-disinfection post-milkingManual spraying using a trigger sprayerManual spraying using an electronic sprayerAutomated spraying by robot |
| Application rate(s) and frequency | Application rate: RTU product, 1,92-1,96% L-(+)-lactic acid - Number and timing of application: 2-3 times a day (after each milking) Application rate: 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 | HDPE jerrycan: 5-60 kg HDPE drum: 60-200 kg HDPE IBC: 600-1000 kg |
4.1.1. Use-specific instructions
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
5.1. Instructions for use
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 or spraying. 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.
5.2. Risk mitigation measures
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.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of 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
First aid instructions
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: 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: rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
Emergency measure to protect the environment
Environmental precautions: no special environmental measures are necessary. Clean contaminated articles and floor in accordance with the environmental legislation.
Methods and material for containment: absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents).
5.4. Instructions for safe disposal of the product and its packaging
At the end of the application, 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.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
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 5
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Dip es poly-film Spray | Dip es poly-film Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Lacti-Shield Spray | Lacti-Shield Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | DS 2.0 SP | DS 2.0 SP | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0017 1-5 | EU-0028957-0017 1-5 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 1,92 % (w/w) |
1. META SPC 6 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 6 identifier
| Identifier | Meta SPC: mSPC6 |
1.2. Suffix to the authorisation number
| Number | 1-6 |
1.3. Product type(s)
| Product type(s) | PT03: Veterinary hygiene |
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 (%) |
|---|---|---|---|---|---|
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 6,8 - 6,8 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 6
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
| 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
4.1. Use description
Table 1
Use # 6.1 – Teat-disinfection post-milking by manual or automated dipping or spraying
| 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 Method: Spraying Detailed description: Teat-disinfection post-milkingManual spraying using a trigger sprayerManual spraying using an electronic sprayerAutomated spraying 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) 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 |
4.1.1. Use-specific instructions
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 6
5.1. Instructions for use
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 or spraying. 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.
5.2. Risk mitigation measures
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.
Google, gloves and coverall material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of 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
First aid instructions
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.
Emergency measure to protect the environment
Environmental precautions: no special environmental measures are necessary. Clean contaminated articles and floor in accordance with the environmental legislation.
Methods and material for containment: absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents).
5.4. Instructions for safe disposal of the product and its packaging
At the end of the application, 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.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
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 6
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Dip es poly-spray DLX | Dip es poly-spray DLX | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0028957-0018 1-6 | EU-0028957-0018 1-6 | |||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | active substance | active substance | 79-33-4 | 79-33-4 | 201-196-2 | 6,8 % (w/w) |
1. META SPC 7 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 7 identifier
| Identifier | Meta SPC: mSPC7 |
1.2. Suffix to the authorisation number
| Number | 1-7 |
1.3. Product type(s)
| Product type(s) | PT04: Food and feed area |
2. META SPC 7 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 7
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| L-(+)-lactic acid | active substance | 79-33-4 | 201-196-2 | 16 - 17,6 % (w/w) | |
| Methanesulphonic acid | Methanesulphonic acid | Non-Active substance | 75-75-2 | 200-898-6 | 6,3 - 7 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 7
| Formulation type(s) | SL Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
| Hazard statements | H290: May be corrosive to metals. H314: Causes severe skin burns and eye damage. EUH071: Corrosive to the respiratory tract. |
| Precautionary statements | P260: Do not breathe spray. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. 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]. 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 doctor. P310: Immediately call a POISON CENTER. P406: Store in a corrosion resistant container with a resistant inner liner. 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
4.1. Use description
Table 1
Use # 7.1 – Hard surface disinfection by manual or automated foaming
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