See Full Document Text
Official Journal EN
of the European Union L series
2024/1990 23.7.2024
COMMISSION IMPLEMENTING REGULATION (EU) 2024/1990
of 22 July 2024
amending Implementing Regulation (EU) 2023/1763 as regards an administrative change to the
Union authorisation of the biocidal product family ‘Lactic acid Family – Quatchem’
(Text with EEA relevance)
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 2012concerning
the making available on the market and use of biocidal products(1), and in particular Article 50(2) thereof,
Whereas:
(1) On 12 September 2023, Commission Implementing Regulation (EU) 2023/1763(2)granted a Union authorisation
with authorisation number EU-0030143-0000 to Arrow Regulatory (Ireland) Limited for the making available on
the market and use of the biocidal product family ‘Lactic acid Family – Quatchem’.
(2) On 25 January 2024, Arrow Regulatory (Ireland) Limited submitted a notification to the European Chemicals
Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU)
No 354/2013(3) regarding an administrative change to the Union authorisation for the biocidal product family
‘Lactic acid Family – Quatchem’ as referred to in Title 1, Section 1, of the Annex to that Regulation.
(3) Arrow Regulatory (Ireland) Limited proposed to transfer the authorisation to a new holder established in the
European Economic Area as set out in Title 1, Section 1, point 3, of the Annex to Implementing Regulation (EU)
No 354/2013. The notification was recorded in the Register for Biocidal Productsunder the case number
BC-PG091934-25.
(4) On 12 March 2024, the Agency submitted an opinion(4)to the Commission on the proposed change, in accordance
with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendment to
the existing authorisation sought by the authorisation holder falls under Article 50(3), point (a), of Regulation (EU)
No 528/2012, that the parties have agreed to the transfer of the authorisation, that the prospective new
authorisation holder is established in the Union, and that after the implementation of the changes, the conditions of
Article 19 of Regulation (EU) No 528/2012 are still met.
(5) On 3 April 2024, the Agency transmitted to the Commission the revised summary of the biocidal product
characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing
Regulation (EU) No 354/2013.
(6) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union
authorisation of the biocidal product family ‘Lactic acid Family – Quatchem’.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2023/1763 of 12 September 2023 granting a Union authorisation for the biocidal
product family ‘Lactic acid Family – Quatchem’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of
the Council (OJ L 225, 13.9.2023, p. 5, ELI: http://data.europa.eu/eli/reg_impl/2023/1763/oj).
(3) 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).
(4) ECHA opinion on an administrative change of the Union authorisation of ‘Lactic acid Family – QuatChem’ of 12 March 2024, Opinion
No. UTR-C-1719298-59-00/F, https://echa.europa.eu/opinions-on-union-authorisation.
ELI: http://data.europa.eu/eli/reg_impl/2024/1990/oj 1/16EN
OJ L, 23.7.2024
(7) Save for the amendment regarding the transfer of the authorisation to a new holder, all other information included
in the summary of the biocidal product characteristics of ‘Lactic acid Family – Quatchem’ as set out in the Annex to
Implementing Regulation (EU) 2023/1763 remains unchanged. In order to enhance clarity and to ease the access of
users and interested parties to the final consolidated version of the summary of biocidal product characteristics
which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2023/1763 should be replaced
in its entirety.
HAS ADOPTED THIS REGULATION:
Article 1
Implementing Regulation (EU) 2023/1763 is amended as follows:
(1) in Article 1, first paragraph, the name ‘Arrow Regulatory (Ireland) Limited’ is replaced by the name ‘Neogen Italia
S.r.l.’;
(2) the Annex is replaced by the text 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, 22 July 2024.
For the Commission
The President
Ursula VON DER LEYEN
2/16 ELI: http://data.europa.eu/eli/reg_impl/2024/1990/ojEN
OJ L, 23.7.2024
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
Lactic acid Family – Quatchem
Product type(s)
PT03: Veterinary hygiene
Authorisation number: EU-0030143-0000
R4BP asset number: EU-0030143-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
Name Lactic acid Family – Quatchem
1.2. Product type(s)
Product type(s) PT03: Veterinary hygiene
1.3. Authorisation holder
Name Neogen Italia S.r.l.
Address c/o REGUS Palazzo Bernini
Name and address of the authorisation
Centro Direzionale Milano Due, Via Fratelli Cervi
holder
snc
20054 - Segrate, Milano
Italy
Authorisation number EU-0030143-0000
R4BP asset number EU-0030143-0000
Date of the authorisation 3 October 2023
Expiry date of the authorisation 30 September 2033
1.4. Manufacturer(s) of the product
Name of manufacturer Quat-Chem Ltd. A Neogen Company
Address of manufacturer 1-4 Sandfield Industrial Park, Dodgson Street, Rochdale
OL16 5SJ Lancashire United Kingdom of Great Britain and
Northern Ireland (the)
Location of manufacturing sites Quat-Chem Ltd. A Neogen Company site 1
1-4 Sandfield Industrial Park, Dodgson Street, Rochdale
OL16 5SJ Lancashire United Kingdom of Great Britain and
Northern Ireland (the)
ELI: http://data.europa.eu/eli/reg_impl/2024/1990/oj 3/16EN
OJ L, 23.7.2024
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 4206 AC Gorinchem Netherlands (the)
Location of manufacturing sites Purac Biochem bv site 1
Arkelsedijk 46 4206 AC Gorinchem Netherlands (the)
Active substance L-(+)-lactic acid
Name of manufacturer Jungbunzlauer S. A
Address of manufacturer Z.I. et Portuaire, B.P. 32 FR-67390 Marckolsheim France
Location of manufacturing sites Jungbunzlauer S. A site 1
Z.I. et Portuaire, B.P. 32 FR-67390 Marckolsheim France
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
Common IUPAC name Function CAS number EC number Content (%)
name
L-(+)-lactic active substance 79-33-4 201-196-2 4 - 4 % (w/w)
acid
2.2. Type(s) of formulation
Formulation type(s) AL Any other liquid
PART II
SECOND INFORMATION LEVEL - META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
Identifier Meta SPC: meta SPC 1
1.2. Suffix to the authorisation number
Number 1-1
1.3. Product type(s)
Product type(s) PT03: Veterinary hygiene
4/16 ELI: http://data.europa.eu/eli/reg_impl/2024/1990/ojEN
OJ L, 23.7.2024
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
Common IUPAC name Function CAS number EC number Content (%)
name
L-(+)-lactic active substance 79-33-4 201-196-2 4 - 4 % (w/w)
acid
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 H315: Causes skin irritation.
H318: Causes serious eye damage.
Precautionary statements P280: Wear protective gloves.
P280: Wear eye protection.
P264: Wash hands thoroughly after handling.
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.
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.
P362+P364: Take off contaminated clothing and wash it
before reuse.
P501: Dispose of contents to hazardous or special waste col
lection point in accordance with national regulations.
P501: Dispose of container to hazardous or special waste
collection point in accordance with national regulations.
ELI: http://data.europa.eu/eli/reg_impl/2024/1990/oj 5/16EN
OJ L, 23.7.2024
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description 1
Table 1.
Use # 1.1 – Post milking teat disinfection – manual dipping
Product type PT03: Veterinary hygiene
Where relevant, an exact description of -
the authorised use
Target organism(s) (including devel Scientific name: Bacteria
opment stage) Common name: Bacteria
Development stage: -
Scientific name: Yeasts
Common name: Yeasts
Development stage: -
Field(s) of use indoor use
Teat disinfection post-milking by manual dipping using a dip cup
Application method(s) Method: Manual dipping using a dip cup
Detailed description: Contact time for dipping at 30 oC in dirty conditions:
- 5 minutes for bacteria and yeasts.
Application rate(s) and frequency Application Rate: 5 to 10 ml per teat
Dilution (%): RTU (Ready-to-use) product
Number and timing of application:
up to twice per day
Category(ies) of users professional
Pack sizes and packaging material 1 000litre high density polyethylene (HDPE) container with HDPE clo
sure;
200 litre plastic drum with HDPE closure;
25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;
5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.
4.1.1. Use-specific instructions for use
See general directions for use.
Product to be applied post-milking by use of a dipping cup.
Pre-clean teat with dry wipe, pour the product into the reservoir of the dip cup. When using a dip cup, the cup is
applied to each teat in turn and the operator squeezes the product from the reservoir into the cup. The cup has a
non-return value so any residual product cannot go back into the reservoir.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
6/16 ELI: http://data.europa.eu/eli/reg_impl/2024/1990/ojEN
OJ L, 23.7.2024
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.
4.2. Use description 2
Table 2.
Use # 1.2 – Post milking teat disinfection - spraying
Product type PT03: Veterinary hygiene
Where relevant, an exact description of -
the authorised use
Target organism(s) (including devel Scientific name: Bacteria
opment stage) Common name: Bacteria
Development stage: -
Scientific name: Yeasts
Common name: Yeasts
Development stage: -
Field(s) of use indoor use
Teat disinfection post-milking by using hand-held sprayer
Application method(s) Method: Manual spraying using hand-held sprayer
Detailed description: Contact time for spraying at 30 oC in dirty condi
tions: - 5 minutes for bacteria and yeasts.
Application rate(s) and frequency Application Rate: 5 to 10 ml per teat
Dilution (%): RTU product
Number and timing of application:
up to twice per day
Category(ies) of users professional
Pack sizes and packaging material 1 000litre HDPE container with HDPE closure;
200 litre plastic drum with HDPE closure;
25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;
5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.
4.2.1. Use-specific instructions for use
See general directions for use.
Product to be applied post-milking by use of a hand-held sprayer.
ELI: http://data.europa.eu/eli/reg_impl/2024/1990/oj 7/16EN
OJ L, 23.7.2024
Pre-clean teat with dry wipe, pour the product into the reservoir of the sprayer. The operator will spray each
animal once after milking.
4.2.2. Use-specific risk mitigation measures
See general directions for use.
Professional users have to ensure that professional bystanders are not present in the treatment area during
disinfection process by spraying. If it is necessary for professional bystanders to be present, professional users
have to ensure that those bystanders wear the same type of PPE as the operator.
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to
protect the environment
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. 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
See use-specific instruction for use of meta SPC 1.
Always read the label or leaflet before use.
The product must be brought to room temperature before use. The amount of product applied per teat is
dependent upon the animal being treated. For large mammals (cows, camels) – up to 10 ml per teat, and for small
mammals (sheep, goats) – up to 5 ml per teat. Make sure that the teats are fully covered with disinfectant. To
ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep
the cows standing for at least 5 minutes).
5.2. Risk mitigation measures
The use of eye protection consistent with European standard EN ISO 16321 or equivalent during handling of the
product is mandatory.
Avoid hand to eye transfer.
Wear protective chemical resistant gloves during product handling phase (nitrile gloves – classified under
European standards EN ISO 374 or EN 455 or equivalent).
The full titles of the European standards indicated here are available under section 6.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect
the environment
IF ON SKIN: Immediately wash with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
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 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.
8/16 ELI: http://data.europa.eu/eli/reg_impl/2024/1990/ojEN
OJ L, 23.7.2024
5.4. Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements.
Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local
requirements. Avoid release to an individual waste water treatment plant.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children.
Store in original container tightly closed.
Store between 0 °C and + 30 °C.
Shelf life: 24 months
6. OTHER INFORMATION
The full titles of the European standards referenced in section 5.2 ‘Risk mitigation measures’ are :
EN ISO 16321 - Eye and face protection for occupational use
EN ISO 374 – Protective gloves against dangerous chemicals and microorganisms
EN 455 - Medical gloves for single use
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) Synodex Market area: EU
Lactopost Market area: EU
Lactopost Y Market area: EU
Lactopost Market area: EU
Plus
Lactopost Market area: EU
Extra
Synodex Y Market area: EU
Synodex Market area: EU
Extra
Synodex Plus Market area: EU
Udder X Market area: EU
Teat Care Market area: EU
Lacto Gold Market area: EU
Lacto Extra Market area: EU
Lactogold Market area: EU
Lacto Spray Market area: EU
ELI: http://data.europa.eu/eli/reg_impl/2024/1990/oj 9/16EN
OJ L, 23.7.2024
Authorisation number EU-0030143-0001 1-1
Common IUPAC name Function CAS number EC number Content (%)
name
L-(+)-lactic active substance 79-33-4 201-196-2 4
acid
7.2. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) Laxsan Market area: EU
Hexsan Market area: EU
Lactopost R Market area: EU
Laxsan R Market area: EU
Hexfoam Market area: EU
Deosan LA1 Market area: EU
Hexsan Extra Market area: EU
Hexsan Plus Market area: EU
Laxsan Plus Market area: EU
Laxsan Extra Market area: EU
Hexsan R Market area: EU
LA1 Market area: EU
Condition Market area: EU
Pink
Authorisation number EU-0030143-0002 1-1
Common IUPAC name Function CAS number EC number Content (%)
name
L-(+)-lactic active substance 79-33-4 201-196-2 4
acid
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
Identifier Meta SPC: meta SPC 2
1.2. Suffix to the authorisation number
Number 1-2
10/16 ELI: http://data.europa.eu/eli/reg_impl/2024/1990/ojEN
OJ L, 23.7.2024
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 4 - 4 % (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.
EUH208: Contains <name of sensitising substance>. May
produce an allergic reaction.
Precautionary statements P280: Wear protective gloves.
P280: Wear eye protection.
P264: Wash hands thoroughly after handling.
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.
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.
P362+P364: Take off contaminated clothing and wash it
before reuse.
P501: Dispose of contents to hazardous or special waste col
lection point in accordance with national regulations.
P501: Dispose of container to hazardous or special waste
collection point in accordance with national regulations.
ELI: http://data.europa.eu/eli/reg_impl/2024/1990/oj 11/16EN
OJ L, 23.7.2024
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description 1
Table 1.
Use # 3.1 – Post milking teat disinfection – manual dipping
Product type PT03: Veterinary hygiene
Where relevant, an exact description of -
the authorised use
Target organism(s) (including devel Scientific name: Bacteria
opment stage) Common name: Bacteria
Development stage: -
Scientific name: Yeasts
Common name: Yeasts
Development stage: -
Field(s) of use indoor use
Teat disinfection post-milking by manual dipping using a dip cup
Application method(s) Method: Manual dipping using a dip cup
Detailed description: Contact time for dipping at 30 oC in dirty conditions:
- 5 minutes for bacteria and yeasts.
Application rate(s) and frequency Application Rate: 5 to 10 ml per teat
Dilution (%): RTU product
Number and timing of application:
up to twice per day
Category(ies) of users professional
Pack sizes and packaging material 1 000litre HDPE container with HDPE closure;
200 litre plastic drum with HDPE closure;
25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;
5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.
4.1.1. Use-specific instructions for use
See general directions for use.
Product to be applied post-milking by use of a dipping cup.
Pre-clean teat with dry wipe, pour the product into the reservoir of the dip cup. When using a dip cup, the cup is
applied to each teat in turn and the operator squeezes the product from the reservoir into the cup. The cup has a
non-return value so any residual product cannot go back into the reservoir.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
12/16 ELI: http://data.europa.eu/eli/reg_impl/2024/1990/ojEN
OJ L, 23.7.2024
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.
4.2. Use description 2
Table 2.
Use # 3.2 – Post milking teat disinfection - spraying
Product type PT03: Veterinary hygiene
Where relevant, an exact description of -
the authorised use
Target organism(s) (including devel Scientific name: Bacteria
opment stage) Common name: Bacteria
Development stage: -
Scientific name: Yeasts
Common name: Yeasts
Development stage: -
Field(s) of use indoor use
Teat disinfection post-milking by using hand-held sprayer
Application method(s) Method: Manual spraying using hand-held sprayer
Detailed description: Contact time for spraying at 30 oC in dirty condi
tions: - 5 minutes for bacteria and yeasts.
Application rate(s) and frequency Application Rate: 5 to 10 ml per teat
Dilution (%): RTU product
Number and timing of application:
up to twice per day
Category(ies) of users professional
Pack sizes and packaging material 1 000litre HDPE container with HDPE closure;
200 litre plastic drum with HDPE closure;
25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;
5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.
4.2.1. Use-specific instructions for use
See general directions for use.
Product to be applied post-milking by use of a hand-held sprayer.
ELI: http://data.europa.eu/eli/reg_impl/2024/1990/oj 13/16EN
OJ L, 23.7.2024
Pre-clean teat with dry wipe, pour the product into the reservoir of the sprayer. The operator will spray each
animal once after milking.
4.2.2. Use-specific risk mitigation measures
See general directions for use.
Professional users have to ensure that professional bystanders are not present in the treatment area during
disinfection process by spraying. If it is necessary for professional bystanders to be present, professional users
have to ensure that those bystanders wear the same type of PPE as the operators.
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to
protect the environment
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. 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
See use-specific instruction for use of meta SPC 2.
Always read the label or leaflet before use.
The product must be brought to room temperature before use. The amount of product applied per teat is
dependent upon the animal being treated. For large mammals (cows, camels) – up to 10 ml per teat, and for small
mammals (sheep, goats) – up to 5 ml per teat. Make sure that the teats are fully covered with disinfectant. To
ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep
the cows standing for at least 5 minutes).
5.2. Risk mitigation measures
The use of eye protection consistent with European standard EN ISO 16321 or equivalent during handling of the
product is mandatory.
Avoid hand to eye transfer.
Wear protective chemical resistant gloves during product handling phase (nitrile gloves – classified under
European standards EN ISO 374 or EN 455 or equivalent).
The full titles of the European standards indicated here are available under section 6.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect
the environment
IF ON SKIN: Immediately wash with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
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.
14/16 ELI: http://data.europa.eu/eli/reg_impl/2024/1990/ojEN
OJ L, 23.7.2024
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
At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements.
Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local
requirements. Avoid release to an individual waste water treatment plant.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children.
Store in original container tightly closed.
Store between 0 °C and + 30 °C.
Shelf life: 24 months
6. OTHER INFORMATION
The full titles of the EN standards referred to in section 5.2 are the following:
EN ISO 16321 - Eye and face protection for occupational use
EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms
EN 455 - Medical gloves for single use
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) Synoshield Market area: EU
Lactopost G Market area: EU
Synoshield Market area: EU
P
Lactopost P Market area: EU
Synoshield Market area: EU
G
Lactoshield Market area: EU
Lactoshield Market area: EU
Plus
Lactoshield Market area: EU
Extra
Synoshield Market area: EU
Extra
Synoshield Market area: EU
Plus
Lactopost Market area: EU
Protect
Udder Market area: EU
Shield
Teat Care Market area: EU
Mint Lacto Market area: EU
Plus
Lacto Care G Market area: EU
ELI: http://data.europa.eu/eli/reg_impl/2024/1990/oj 15/16EN
OJ L, 23.7.2024
Lactosal Market area: EU
Lacto Care P Market area: EU
Previoshield Market area: EU
Authorisation number EU-0030143-0003 1-2
Common IUPAC name Function CAS number EC number Content (%)
name
L-(+)-lactic active substance 79-33-4 201-196-2 4
acid
16/16 ELI: http://data.europa.eu/eli/reg_impl/2024/1990/oj