LegalizeCommission Implementing Regulation (EU) 2025/1171 of 16 June 2025 granting a Union authorisation for the biocidal product family PRODHYNET’s Lactic acid based products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
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 |
| --- | --- | --- |
| 2025/1171 | 17.6.2025 |
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 44(5), first subparagraph, thereof,
Whereas:
- (1) On 26 April 2019, PRODHYNET SA submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 2 for Union authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘PRODHYNET's Lactic acid based products’, of product-type 3, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-XX051283-02 in the Register for Biocidal Products. The application also indicated the case number of the related reference biocidal product family ‘Kersia’s Lactic acid based products’ later authorised by Commission Implementing Regulation (EU) 2024/2188 3, with authorisation number EU-0031195-0000.
- (2) The biocidal product family ‘PRODHYNET'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 24 April 2024, the Agency submitted to the Commission its opinion 4 and the draft summary of the biocidal product characteristics (‘SPC’) of ‘PRODHYNET's Lactic acid based products’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.
- (4) In its opinion, the Agency concludes that the proposed differences between the biocidal product family ‘PRODHYNET’s Lactic acid based products’ and the related reference biocidal product family ‘Kersia’s Lactic acid based products’, are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 5, and that based on the assessment of the related reference biocidal product family ‘Kersia’s Lactic acid based products’ and subject to compliance with the draft SPC, the same biocidal product family ‘PRODHYNET’s Lactic acid based products’ meets the conditions laid down in Article 19(6) of Regulation (EU) No 528/2012.
- (5) On 22 May 2024, the Agency also transmitted to the Commission the draft SPC of ‘PRODHYNET’s Lactic acid based products’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.
- (6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family ‘PRODHYNET’s Lactic acid based products’.
- (7) The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘Kersia’s Lactic acid based products’.
- (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-0033504-0000 is hereby granted to PRODHYNET SA for the making available on the market and use of the same biocidal product family ‘PRODHYNET’s Lactic acid based products’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 7 July 2025 until 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, 16 June 2025.
For the Commission
The President
Ursula VON DER LEYEN
Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj).
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 (OJ L, 2024/2188, 4.9.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2188/oj).
European Chemicals Agency opinion of 24 April 2024 on the Union authorisation of the same biocidal product family ‘PRODHYNET's Lactic acid based products’, UBP-C-1719023-18-00/F, https://echa.europa.eu/opinions-on-union-authorisation.
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).
ANNEX
Summary of product characteristics for a biocidal product family
PRODHYNET’s Lactic acid based products
Product type(s)
PT03: Veterinary hygiene
Authorisation number EU-0032621-0000
R4BP asset number EU-0032621-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
| Name | PRODHYNET’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 | PRODHYNET SA |
| Name and address of the authorisation holder | Address | 11 avenue des châtelets 22440 PLOUFRAGAN FR |
| Authorisation number | EU-0032621-0000 | |
| R4BP asset number | EU-0032621-0000 | |
| Date of the authorisation | 7 July 2025 | |
| 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 / Dinard 55, Boulevard Jules Verger; BP 10180 35803 DINARD Cedex France HYPRED SAS - KERSIA Group / Vaas 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 / Estella 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 | Jungbunzlauer S.A. 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) 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) | Trade name(s) | Trade name(s) | DOUPIS FLUIDE | DOUPIS FLUIDE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PRO AL SPRAY | PRO AL SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GALACTIK FL | GALACTIK FL | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Spray Guard | Spray Guard | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ExtraGuard Spray | ExtraGuard Spray | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ROBOLAK FL | ROBOLAK FL | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GALACTIK PULVE | GALACTIK PULVE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | LACTI FLUIDE | LACTI FLUIDE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | AGRILAC FLUIDE | AGRILAC FLUIDE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | LACTI SPRAY FLUIDE | LACTI SPRAY FLUIDE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HYGIALAC FLUIDE | HYGIALAC FLUIDE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | BRETALAC FLUIDE | BRETALAC FLUIDE | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032621-0001 1-1 | EU-0032621-0001 1-1 | EU-0032621-0001 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 | 8,4 % (w/w) | |
| Sodium p-cumenesulphonate | Non-Active substance | Non-Active substance | 15763-76-5 | 15763-76-5 | 239-854-6 | 1,32 % (w/w) | |
| Diethanolamine | Non-Active substance | Non-Active substance | 111-42-2 | 111-42-2 | 203-868-0 | 4,234 % (w/w) |
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) 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) | Trade name(s) | Trade name(s) | EDDAR FILM | EDDAR FILM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | DOUPIS FILM | DOUPIS FILM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GALACTIK EP | GALACTIK EP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Xtrem Guard | Xtrem Guard | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ExtraGuard Xtrem | ExtraGuard Xtrem | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | LACTI EPAIS | LACTI EPAIS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HYGIALAC EPAIS | HYGIALAC EPAIS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | TREMPAGE EPAIS LACTI | TREMPAGE EPAIS LACTI | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | AGRILAC EPAIS | AGRILAC EPAIS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | FILMOGENE | FILMOGENE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | AGRIFILM | AGRIFILM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | BRETADINE | BRETADINE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | BRETALAC FILM | BRETALAC FILM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GEL TRAYON | GEL TRAYON | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | APROMADINE | APROMADINE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | CELTADINE | CELTADINE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | DALFILM | DALFILM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | FILM-AGRI | FILM-AGRI | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HYGIA’TREMP | HYGIA’TREMP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HYGIAFILM | HYGIAFILM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PRODINE | PRODINE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PRO AL | PRO AL | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ADIEL FILM | ADIEL FILM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | CORIAFILM | CORIAFILM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GANAFILM | GANAFILM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | MAGDINE | MAGDINE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | NUTRIDINE | NUTRIDINE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PLUSAFILM | PLUSAFILM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PROXAFILM | PROXAFILM | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032621-0002 1-2 | EU-0032621-0002 1-2 | EU-0032621-0002 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 | 8,4 % (w/w) | |
| Sodium p-cumenesulphonate | Non-Active substance | Non-Active substance | 15763-76-5 | 15763-76-5 | 239-854-6 | 1,32 % (w/w) | |
| Sodium 2-ethylhexyl sulfate | Non-Active substance | Non-Active substance | 126-92-1 | 126-92-1 | 204-812-8 | 2,1 % (w/w) | |
| Diethanolamine | Non-Active substance | Non-Active substance | 111-42-2 | 111-42-2 | 203-868-0 | 3,92 % (w/w) |
ELI: http://data.europa.eu/eli/reg_impl/2025/1171/oj
ISSN 1977-0677 (electronic edition)
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