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
Date: 2024-07-22
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal welfare, biocide, chemical product, decontamination, market approval, organic acid, pharmaceutical product








L_202401990EN.000101.fmx.xml












Official Journal of the European Union


EN
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 2012 concerning 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’.












(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
            





(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.




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 and address of the authorisation holder


Name


Neogen Italia S.r.l.




Address







c/o REGUS Palazzo Bernini




Centro Direzionale Milano Due, Via Fratelli Cervi 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)








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 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







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




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


4 - 4 % (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


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 collection point in accordance with national regulations.
P501: Dispose of container to hazardous or special waste collection point in accordance with national regulations.




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 development stage)


Scientific name: Bacteria
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


1 000  litre high density polyethylene (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.
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 development stage)


Scientific name: Bacteria
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 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


1 000  litre 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.
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.
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 Plus


Market area: EU




Lactopost Extra


Market area: EU




Synodex Y


Market area: EU




Synodex Extra


Market area: EU




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




Authorisation number


EU-0030143-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


4




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 Pink


Market area: EU




Authorisation number


EU-0030143-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


4




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




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 collection point in accordance with national regulations.
P501: Dispose of container to hazardous or special waste collection point in accordance with national regulations.




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 development stage)


Scientific name: Bacteria
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








 


1 000  litre 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.
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 development stage)


Scientific name: Bacteria
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 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








 


1 000  litre 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.
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.
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 P


Market area: EU




Lactopost P


Market area: EU




Synoshield G


Market area: EU




Lactoshield


Market area: EU




Lactoshield Plus


Market area: EU




Lactoshield Extra


Market area: EU




Synoshield Extra


Market area: EU




Synoshield Plus


Market area: EU




Lactopost Protect


Market area: EU




Udder Shield


Market area: EU




Teat Care


Market area: EU




Mint Lacto Plus


Market area: EU




Lacto Care G


Market area: EU




Lactosal


Market area: EU




Lacto Care P


Market area: EU




Previoshield


Market area: EU




Authorisation number


EU-0030143-0003 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


4







ELI: http://data.europa.eu/eli/reg_impl/2024/1990/oj
ISSN 1977-0677 (electronic edition)