Commission Implementing Regulation (EU) 2024/2188 of 3 September 2024 granting a Union authorisation for the biocidal product family Kersia’s Lactic acid based products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2024-09-03
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, biocide, dairy cow, decontamination, market approval, organic acid








L_202402188EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2188


4.9.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2188
of 3 September 2024
         
granting a Union authorisation for the biocidal product family ‘Kersia’s Lactic acid based products’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(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 44(5), first subparagraph, thereof,

Whereas:







(1)


On 26 April 2019, HYPRED SAS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘Kersia’s Lactic acid based products’ of product-type 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-CH051281-59 in the Register for Biocidal Products.












(2)


‘Kersia’s Lactic acid based products’ contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 3.












(3)


On 30 November 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 30 June 2023, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Kersia’s Lactic acid based products’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘Kersia’s Lactic acid based products’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. The opinion does not recommend the authorisation of the use of the products as teat disinfectants applied prior to milking, due to an exceedance of the acceptable daily intake of a co-formulant contained in all products of the biocidal product family ‘Kersia’s Lactic acid based products’.












(6)


On 13 July 2023, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘Kersia’s Lactic acid based products’ in accordance with the recommendations in that opinion.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0031195-0000 is hereby granted to HYPRED SAS for the making available on the market and use of the biocidal product family ‘Kersia’s Lactic acid based products’ subject to compliance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 24 September 2024 to 31 August 2034.


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, 3 September 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)  Opinion of the Biocidal Products Committee of 6 June 2023 on the Union authorisation of ‘Kersia’s Lactic acid based products’ (ECHA/BPC/381/2023), https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY


Kersia’s Lactic acid based products



Product type(s)
: PT03: Veterinary hygiene


Authorisation number
: EU-0031195-0000


R4BP asset number
: EU-0031195-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Kersia’s Lactic acid based products




1.2.   Product type(s)







Product type(s)


PT03: Veterinary hygiene




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


HYPRED SAS




Address


55, boulevard Jules Verger 35803 DINARD FR




Authorisation number


 


EU-0031195-0000





R4BP asset number



 


EU-0031195-0000




Date of the authorisation


 


24 September 2024




Expiry date of the authorisation


 


31 August 2034




1.4.   Manufacturer(s) of the product







Name of manufacturer


HYPRED SAS - KERSIA Group




Address of manufacturer


55, Boulevard Jules Verger BP10180 35803 DINARD France




Location of manufacturing sites


HYPRED SAS - KERSIA Group 55, Boulevard Jules Verger; BP 10180 35803 DINARD Cedex France
HYPRED SAS - KERSIA Group Zone Industrielle Le Roineau 72500 VAAS France
Medentech Ltd – KERSIA Group Clonard Road Y35Y7WY WEXFORD Ireland
SOPURA – KERSIA Group Parc Paysager de Tyberchamps 14 7180 SENEFFE Belgium
KERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 BORNHEIM – SECHTEM Germany
Holchem Laboratories Ltd – KERSIA Group Gateway House, Pilsworth Road, Pilsworth Industrial Estate BL9 8RD Bury United Kingdom of Great Britain and Northern Ireland (the)
KERSIA AUSTRIA GmbH PFONGAUERSTRAßE 17 5202 NEUMARKT AM WALLERSEE Austria
KERSIA POLSKA Sp.z.o.o Niepruszewo, ul. Kasztanowa 4 64-320 BUK Poland
KERSIA ITALIA S.r.l Strada Montodine – Gombito; Loc. Cà Nova 26010 RIPALTA ARPINA (CR) Italy
KERSIA IBERICA SL Pol. Miguel Eguía C/Zarapuz s/n 31200 ESTELLA (NAVARRA) Spain
Kilco Holdings Ltd – KERSIA Group Broomhouses 2 Industrial Estate; Old Glasgow Road DG11 2SD LOCKERBIE United Kingdom of Great Britain and Northern Ireland (the)
Kilco (International) Ltd – KERSIA Group 1A Trench Road Mallusk; Newtownabbey BT36 4TY CO ANTRIM Ireland
SOPURA Quimica – KERSIA Group Pol. Ind. “La Canaleta“; Avinguda Júpiter n° 7 25300 TARREGA (LLEIDA) Spain
KERSIA DEUTSCHLAND GmbH Oberbrühlstraße 16-18 87700 Memmingen Germany




1.5.   Manufacturer(s) of the active substance(s)







Active substance


L-(+)-lactic acid




Name of manufacturer


PURAC Bioquimica SA




Address of manufacturer


Gran Vial 19-25 8160 Montmelo - Barcelona Spain




Location of manufacturing sites


PURAC Bioquimica SA Gran Vial 19-25 8160 Montmelo - Barcelona Spain
PURAC BIOCHEM BV Arkelsedijk 46 4206 AC Gorinchem Netherlands (the)
Purac Sínteses Ltda Av. Rui Barbosa, 521 CEP 28015-520 Campos dos Goytacazes - RJ Brazil
Purac America Inc. 650 Industrial Park Drive, P.O. Box 38 NE 68008 Blair United States (the)
Purac (Corbion) Thailand Ltd Tambol Huay Pong, Amphoe Muang 21150 Rayong Thailand













Active substance


L-(+)-lactic acid




Name of manufacturer


Jungbunzlauer S.A.




Address of manufacturer


Z.I. Portuaire BP 32 67390 Marckolsheim France




Location of manufacturing sites


Z.I. Portuaire BP 32 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


8,4 - 8,4 % (w/w)




Sodium p-cumenesulphonate


 


Non-active substance


15763-76-5


239-854-6


1,32 - 1,32 % (w/w)




Sodium 2-ethylhexyl sulfate


 


Non-active substance


126-92-1


204-812-8


0 - 2,1 % (w/w)




Diethanolamine


 


Non-active substance


111-42-2


203-868-0


3,92 - 4,234 % (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 - Dipping, foaming, spraying ready to use products




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


8,4 - 8,4 % (w/w)




Sodium p-cumenesulphonate


 


Non-active substance


15763-76-5


239-854-6


1,32 - 1,32 % (w/w)




Diethanolamine


 


Non-active substance


111-42-2


203-868-0


4,234 - 4,234 % (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


H319: Causes serious eye irritation.




Precautionary statements


P264: Wash hands thoroughly after handling.
P280: Wear eye protection.
P280: Wear face protection.
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 attention.
P337+P313: If eye irritation persists: Get medical advice.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Disinfection of teats of milk producing animals by manual or automated dipping, foaming or spraying after milking







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
Manual or automated disinfection of teats of milk producing animals by dipping, foaming or spraying after milking




Application method(s)


Method: Dipping, foaming or spraying
Detailed description: Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.




Application rate(s) and frequency


Application rate: application rate per animal: - cows and buffaloes 3 to 10 ml (5 to 8 ml recommended) - sheep 1,5 to 5 ml (1,5 to 3 ml recommended) - goats 2,5 to 6 ml (2,5 to 4 ml recommended)
Dilution (%): Ready to use product
Number and timing of application:
Contact time : 5 minutes
Frequency: 2 to 3 times per day




Category(ies) of users


professional




Pack sizes and packaging material


HDPE (High Density Polyethylene) jerrycans 5, 10, 22, 25 and 30 litre
HDPE barrel 60 litre
HDPE drums 120 and 220 litre
HDPE container 640 and 1000 litre




4.1.1.   Use-specific instructions

See general directions for use of meta SPC 1
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 1
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 of meta SPC 1
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1
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 of meta SPC 1
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.
Manual or automatic dipping/foaming/spraying on animal’s teats on the full length of the teat after milking.
Make sure that the teats are fully covered with disinfectant.
Leave the product until next milking.
Keep the animals standing for at least 5 minutes until the product has dried.
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
Avoid contact with eyes.
Wash hands after work.
Product must be brought to a temperature between 20°C and 30°C before use.
5.2.   Risk mitigation measures

Wear chemical goggles or face protection consistent with European Standard EN ISO 16321 or equivalent.
For manual application by spraying: Wear protective chemical resistant gloves consistent with European Standard EN ISO 374 during product handling phase.
Keep out of reach of children.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: If symptoms occur 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.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
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.
Refer to the safety data sheet available for professional user: it contains an emergency phone number.
Large spillage: Mark out, soak up with an inert absorbant and pump in an emergency tank. Never return spills in original containers for re-use. Keep in suitable, properly labelled and closed containers for disposal.
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 the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
The paper towels used for removing the product and drying the teats are disposed in the normal domestic waste.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE
6.   OTHER INFORMATION

Full titles of EN standards and legislation referred to in section 5.2:
EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms.
EN ISO 16321 – Eye and face protection for occupational 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)


NATIDINE


Market area: EU




Bonimal H Lactiliquid


Market area: EU




LACTILIQ


Market area: EU




MilchsäureDip-Spray


Market area: EU




NATILAC


Market area: EU




PRIMAMO


Market area: EU




RBT LACTIC


Market area: EU




ROBOSPRAY LACTIC


Market area: EU




SPRAYLAC


Market area: EU




Bonimal CARE LactiLiquid


Market area: EU




Authorisation number


 


EU-0031195-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


8,4




Sodium p-cumenesulphonate


 


Non-active substance


15763-76-5


239-854-6


1,32




Diethanolamine


 


Non-active substance


111-42-2


203-868-0


4,234




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC: meta SPC 2 - Dipping ready to use products




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


8,4 - 8,4 % (w/w)




Sodium p-cumenesulphonate


 


Non-active substance


15763-76-5


239-854-6


1,32 - 1,32 % (w/w)




Sodium 2-ethylhexyl sulfate


 


Non-active substance


126-92-1


204-812-8


0 - 2,1 % (w/w)




Diethanolamine


 


Non-active substance


111-42-2


203-868-0


3,92 - 3,92 % (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


H319: Causes serious eye irritation.




Precautionary statements


P264: Wash hands thoroughly after handling.
P280: Wear eye protection.
P280: Wear face protection.
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 attention.
P337+P313: If eye irritation persists: Get medical advice.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Disinfection of teats of milk producing animals by manual or automated dipping after milking







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
Manual or automated disinfection of teats of milk producing animals by dipping after milking




Application method(s)


Method: Dipping
Detailed description: Dipping cup or automated dipping machine.




Application rate(s) and frequency


Application rate: application rate per animal: - cows and buffaloes 3 to 10 ml (5 ml recommended) - sheep 1,5 to 5 ml (1,5 ml recommended) - goats 2,5 to 6 ml (2,5 ml recommended)
Dilution (%): Ready to use product
Number and timing of application:
Contact time : 5 minutes
Frequency: 2 to 3 times per day




Category(ies) of users


professional




Pack sizes and packaging material


HDPE (High Density Polyethylene) jerrycans 5, 10, 22, 25 and 30 litre
HDPE barrel 60 litre
HDPE drums 120 and 220 litre
HDPE container 640 and 1000 litre




4.1.1.   Use-specific instructions

See general directions for use of meta SPC 2
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 2
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 of meta SPC 2
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2
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 of meta SPC 2
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

Fill the dipping cup manually or automatically with the ready to use product.
Apply by dipping manually or automatically on animal’s teats on the full length of the teat after milking.
Make sure that the teats are fully covered with disinfectant.
Leave the product until next milking. Keep the animals standing for at least 5 minutes until the product has dried.
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
Avoid contact with eyes.
Wash hands after work.
Product must be brought to a temperature between 20°C and 30°C before use.
5.2.   Risk mitigation measures

Wear chemical goggles or face protection consistent with European Standard EN ISO 16321 or equivalent.
Keep out of reach of children.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: If symptoms occur 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.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
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.
Refer to the safety data sheet available for professional user: it contains an emergency phone number.
Large spillage: Mark out, soak up with an inert absorbant and pump in an emergency tank. Never return spills in original containers for re-use. Keep in suitable, properly labelled and closed containers for disposal.
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 the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
The paper towels used for removing the product and drying the teats are disposed in the normal domestic waste.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE
Store below 30°C
6.   OTHER INFORMATION

Full titles of EN standards and legislation referred to in section 5.2:
EN ISO 16321 – Eye and face protection for occupational 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)


FILMADINE LL


Market area: EU




Authorisation number


 


EU-0031195-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


8,4




Sodium p-cumenesulphonate


 


Non-active substance


15763-76-5


239-854-6


1,32




Diethanolamine


 


Non-active substance


111-42-2


203-868-0


3,92




7.2.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


FILMADINE LC


Market area: EU




FILMADINE C


Market area: EU




Bonimal H Lactidip C


Market area: EU




CERTI CREME C


Market area: EU




CERTI FILM C


Market area: EU




COSMADINE C


Market area: EU




DIPLAC C


Market area: EU




EQUO LACTO C


Market area: EU




FILMADIP C


Market area: EU




FILMALAC C


Market area: EU




FILMALINE C


Market area: EU




FILMATREMP C


Market area: EU




FILMORANGE C


Market area: EU




FP FILM C


Market area: EU




HY-COSMETIC C


Market area: EU




HYPREDIP PLUS C


Market area: EU




INO EXTRA C


Market area: EU




INO FILM C


Market area: EU




LACTIDIP C


Market area: EU




MilchsäureFilmdip-Super C


Market area: EU




PRIMASKIN C


Market area: EU




SUPREMADINE C


Market area: EU




ZOO FILM RED C


Market area: EU




Authorisation number


 


EU-0031195-0003 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


8,4




Sodium p-cumenesulphonate


 


Non-active substance


15763-76-5


239-854-6


1,32




Sodium 2-ethylhexyl sulfate


 


Non-active substance


126-92-1


204-812-8


2,1




Diethanolamine


 


Non-active substance


111-42-2


203-868-0


3,92




7.3.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


FILMADINE


Market area: EU




Bonimal H Lactidip


Market area: EU




CERTI CREME +


Market area: EU




CERTI FILM


Market area: EU




COSMADINE


Market area: EU




DIPLAC


Market area: EU




EQUO LACTO


Market area: EU




FILMADIP


Market area: EU




FILMALAC


Market area: EU




FILMALINE


Market area: EU




FILMATREMP


Market area: EU




FILMORANGE


Market area: EU




FP FILM


Market area: EU




HY-COSMETIC


Market area: EU




HYPREDIP PLUS


Market area: EU




INO EXTRA


Market area: EU




INO FILM


Market area: EU




LACTIDIP


Market area: EU




MilchsäureFilmdip-Super


Market area: EU




PRIMASKIN


Market area: EU




SUPREMADINE


Market area: EU




ZOO FILM RED


Market area: EU




LAURACTIV


Market area: EU




Salus TOP


Market area: EU




LAURAFILM


Market area: EU




Juvelit-extreme


Market area: EU




Bonimal CARE LactiDip


Market area: EU




Authorisation number


 


EU-0031195-0004 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


8,4




Sodium p-cumenesulphonate


 


Non-active substance


15763-76-5


239-854-6


1,32




Sodium 2-ethylhexyl sulfate


 


Non-active substance


126-92-1


204-812-8


2,1




Diethanolamine


 


Non-active substance


111-42-2


203-868-0


3,92







ELI: http://data.europa.eu/eli/reg_impl/2024/2188/oj
ISSN 1977-0677 (electronic edition)