COMMISSION IMPLEMENTING REGULATION (EU) 2024/2175

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2024/2175 | 4.9.2024 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2024/2175 of 3 September 2024 granting a Union authorisation for the biocidal product family ‘Contec Calcium Hypochlorite Product Family’ 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 19 December 2018, Contec Europe submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Contec Calcium Hypochlorite Product Family’ of product-type 2, 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-LY047116-11 in the Register for Biocidal Products. ---|--- (2) | ‘Contec Calcium Hypochlorite Product Family’ contains active chlorine released from calcium hypochlorite 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 2. ---|--- (3) | On 17 July 2023, 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 14 December 2023, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Contec Calcium Hypochlorite Product Family’ 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 ‘Contec Calcium Hypochlorite Product Family’ 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. ---|--- (6) | On 8 January 2024, 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 ‘Contec Calcium Hypochlorite Product Family’. ---|--- (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-0032017-0000 is hereby granted to Contec Europe for the making available on the market and use of the biocidal product family ‘Contec Calcium Hypochlorite Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 24 September 2024 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, 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) ECHA opinion of 22 November 2023 on the Union authorisation of ‘Contec Calcium Hypochlorite Product Family’ (ECHA/BPC/403/2023) (https://echa.europa.eu/opinions-on-union-authorisation). * * * ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY Contec Calcium Hypochlorite Product Family Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Authorisation number: EU-0032017-0000 R4BP asset number: EU-0032017-0000 PART I FIRST INFORMATION LEVEL 1\. ADMINISTRATIVE INFORMATION 1.1. Family name Name | Contec Calcium Hypochlorite Product Family ---|--- 1.2. Product type(s) Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- 1.3. Authorisation holder Name and address of the authorisation holder | Name | Contec Europe ---|---|--- Address | Zl Du Prat, avenue Paul Duplaix, 56000 Vannes, France Authorisation number | EU-0032017-0000 R4BP asset number | EU-0032017-0000 Date of the authorisation | 24 September 2024 Expiry date of the authorisation | 31 August 2034 1.4. Manufacturer(s) of the biocidal products Name of manufacturer | Contec Cleanroom (UK) Ltd. ---|--- Address of manufacturer | Lamport Drive, Heartlands Business Park, NN11 8YT Daventry, United Kingdom Location of manufacturing sites | 5, Badby Park, Heartlands Business Park, NN11 8YT Daventry, United Kingdom 1.5. Manufacturer(s) of the active substance(s) Active substance | Active chlorine released from calcium hypochlorite ---|--- Name of manufacturer | Lonza Cologne GmbH Address of manufacturer | Nattermannallee 1, 50829 Köln, Germany Location of manufacturing sites | 1200 Lower River Road, TN 37310 Charleston, United States 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 (%) ---|---|---|---|---|--- Min | Max Active chlorine released from calcium hypochlorite | | Active Substance | | | 0,06 | 0,2 Calcium hypochlorite | Calcium hypochlorite | Releaser | 7778-54-3 | 231-908-7 | 0,092 | 0,31 2.2. Type(s) of formulation Formulation(s) | AL – Any other liquid ---|--- PART II SECOND INFORMATION LEVEL – META SPC(S) META SPC 1 1\. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier Identifier | meta SPC 1 ---|--- 1.2. Suffix to the authorisation number Number | 1-1 ---|--- 1.3. Product type(s) Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- 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 (%) ---|---|---|---|---|--- Min | Max Active chlorine released from calcium hypochlorite | | Active Substance | | | 0,2 | 0,2 Calcium hypochlorite | Calcium hypochlorite | Releaser | 7778-54-3 | 231-908-7 | 0,31 | 0,31 2.2. Type(s) of formulation of the meta SPC 1 Formulation(s) | AL – Any other liquid ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements | May be corrosive to metals. ---|--- Precautionary statements | Keep only in original packaging. Absorb spillage to prevent material damage. 4\. AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1 Use # 1 – Use 1.1 Hard surface disinfection in cleanrooms by trigger spray and wipe (PT 2) Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | N/A Target organism(s) (including development stage) | Common name: Bacteria Development stage: - Common name: Bacterial spores Development stage: - Common name: Viruses Development stage: - Field(s) of use | Indoor Disinfection of hard non-porous surfaces or equipment by spraying and wiping in cleanrooms which are classified according to ISO 14644-1 in class 1 to 8 or according to GMP EU classification in Grade A to C (e.g. pharmaceutical cleanrooms). Application method(s) | Method: Spraying and wiping Detailed description: The ready-to-use (RTU) product is sprayed onto a cleanroom wipe and the product is applied by wiping on a pre-cleaned, hard, non-porous surface. Application rate(s) and frequency | Dilution (%): ready-to-use (RTU) product Number and timing of application: Application rate: 50 ml/m2. Contact time: 1 minute Application frequency: Specific to the user’s site and requirements. Use temperature: room temperature Category(ies) of users | Professional Pack sizes and packaging material | RTU liquid spray packaged in 1 litre high-density polyethylene (HDPE) trigger spray bottles. 4.1.1. Use-specific instructions for use Before applying the ready-to-use product physically remove contaminants from the surface using a cleanroom wipe. Apply the product by spraying onto a cleanroom wipe and then wipe the surface. Ensure that the entire surface is visibly wet and uniform distribution of the biocidal product should be ensured. Leave for the required contact time of 1 minute for bacteria, bacterial spores and viruses and then wipe to dry the surface. 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 Table 2 Use # 2 – Use 1.2 Hard surface disinfection in cleanrooms by wiping or mopping (PT 2) Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | N/A Target organism(s) (including development stage) | Common name: Bacteria Development stage: – Common name: Bacterial spores Development stage: – Common name: Viruses Development stage: - Field(s) of use | Indoor Disinfection of hard non-porous surfaces or equipment by wiping or mopping in cleanrooms (e.g. pharmaceutical cleanrooms). Application method(s) | Method: Wiping or mopping Detailed description: The disinfection product is poured into a container and applied onto a pre-cleaned, hard, non-porous surface using a cleanroom wipe or mop. Application rate(s) and frequency | Dilution (%): ready-to-use (RTU) product Number and timing of application: Application rate: 100 ml/m2 Contact time: 1 minute Application frequency: Specific to the user’s site and requirements. Use temperature: room temperature Category(ies) of users | Professional Pack sizes and packaging material | RTU liquid packaged in 700 ml, 1 litre and 5 litre capped plastic high-density polyethylene (HDPE) bottles. 4.2.1. Use-specific instructions for use Before applying the ready-to-use product physically remove contaminants from the surface using a cleanroom wipe. Apply the product by pouring the product into a container and using a cleanroom wipe to apply to the surface. Ensure that the entire surface is visibly wet and uniform distribution of the biocidal product should be ensured. Leave for the required contact time of 1 minute for bacteria, bacterial spores and viruses and then wipe to dry the surface. 4.2.2. Use-specific risk mitigation measures See general directions for use 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 (1) OF THE META SPC 1 5.1. Instructions for use See ‘Use-specific instructions for use’ sections for each meta SPC. 5.2. Risk mitigation measures Engineering measures: Ensure there is sufficient ventilation of the area. All meta SPCs: Trigger spraying: only apply in rooms with a minimum ventilation rate of 20 air changes per hour (ACH). Only for disinfection of small size surfaces. All meta SPCs: Wiping and mopping: only apply in rooms with a minimum ventilation rate of 40 ACH. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid instructions IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. Emergency measures to protect the environment Do not discharge into drains or rivers. Contain the spillage using bunding. Absorb into dry earth or sand. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer. Avoid release to an individual wastewater treatment plant. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Store in a cool, well-ventilated area. Keep container tightly closed. Keep away from direct sunlight. Protect from frost. Store at temperatures not exceeding 20 °C. Shelf-life: 12 months 6\. OTHER INFORMATION — 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) | Contec ProChlor Sterile | Market area: EU ---|---|--- Authorisation number | EU-0032017-0001 1-1 Common name | IUPAC name | Function | CAS number | EC number | Content (%) Active chlorine released from calcium hypochlorite | | Active Substance | | | 0,2 Calcium hypochlorite | Calcium hypochlorite | Releaser | 7778-54-3 | 231-908-7 | 0,31 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | Contec ProChlor | Market area: EU ---|---|--- Authorisation number | EU-0032017-0002 1-1 Common name | IUPAC name | Function | CAS number | EC number | Content (%) Active chlorine released from calcium hypochlorite | | Active Substance | | | 0,2 Calcium hypochlorite | Calcium hypochlorite | Releaser | 7778-54-3 | 231-908-7 | 0,31 META SPC 2 1\. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier | meta SPC 2 ---|--- 1.2. Suffix to the authorisation number Number | 1-2 ---|--- 1.3. Product type(s) Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- 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 (%) ---|---|---|---|---|--- Min | Max Active chlorine released from calcium hypochlorite | | Active Substance | | | 0,06 | 0,06 Calcium hypochlorite | Calcium hypochlorite | Releaser | 7778-54-3 | 231-908-7 | 0,092 | 0,092 2.2. Type(s) of formulation of the meta SPC 2 Formulation(s) | AL – Any other liquid ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements | May be corrosive to metals. ---|--- Precautionary statements | Keep only in original packaging. Absorb spillage to prevent material damage. 4\. AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 3 Use # 1 – Use 2.1 Hard surface disinfection in cleanrooms by trigger spray and wipe (PT 2) Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | N/A Target organism(s) (including development stage) | Common name: Bacteria Development stage: - Common name: Yeasts Development stage: - Field(s) of use | Indoor For surface disinfection in cleanrooms which are classified according to ISO 14644-1 in class 1 to 8 or according to GMP EU classification in Grade A to C. The biocidal product is recommended for the control of bacteria and yeast on hard non-porous surfaces that will not come into contact with food or feed by spraying followed by wiping. Application method(s) | Method: Spraying and wiping Detailed description: The ready-to-use (RTU) product is sprayed onto a cleanroom wipe and the product is applied by wiping on a pre-cleaned, hard, non-porous surface. Application rate(s) and frequency | Dilution (%): ready-to-use (RTU) product Number and timing of application: Application rate: 50 ml/m2. Contact time: 5 minutes Application frequency: Specific to the user’s site and requirements. Use temperature: room temperature Category(ies) of users | Professional Pack sizes and packaging material | RTU liquid spray packaged in 1 litre high-density polyethylene (HDPE) trigger spray bottles. 4.1.1. Use-specific instructions for use Before applying the ready-to-use product physically remove contaminants from the surface using a cleanroom wipe. Apply the product by spraying onto a cleanroom wipe and then wipe the surface. Ensure that the entire surface is visibly wet and uniform distribution of the biocidal product should be ensured. Leave for the required contact time of 5 minutes for bacteria and yeast and then wipe to dry the surface. 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 Table 4 Use # 2 – Use 2.2 Hard surface disinfection in cleanrooms by wiping or mopping (PT 2) Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | N/A Target organism(s) (including development stage) | Common name: Bacteria Development stage: - Common name: Yeasts Development stage: - Field(s) of use | Indoor Disinfection of hard non-porous surfaces or equipment by wiping or mopping in cleanrooms which are classified according to ISO 14644-1 in class 1 to 8 or according to GMP EU classification in Grade A to C (e.g. pharmaceutical cleanrooms). Application method(s) | Method: Wiping or mopping Detailed description: The disinfection product is poured into a container and applied onto a pre-cleaned, hard, non-porous surface using a cleanroom wipe or mop. Application rate(s) and frequency | Dilution (%): ready-to-use (RTU) product Number and timing of application: Application rate: 100 ml/m2 Contact time: 5 minutes Application frequency: Specific to the user’s site and requirements. Use temperature: room temperature Category(ies) of users | Professional Pack sizes and packaging material | RTU liquid packaged in 700 ml, 1 litre and 5 litre capped plastic high-density polyethylene (HDPE) bottles. 4.2.1. Use-specific instructions for use Before applying the ready-to-use product physically remove contaminants from the surface using a cleanroom wipe. Apply the product by pouring the product into a container and using a cleanroom wipe to apply to the surface. Ensure that the entire surface is visibly wet and uniform distribution of the biocidal product should be ensured. Leave for the required contact time of 5 minutes for bacteria and yeast and then wipe to dry the surface. 4.2.2. Use-specific risk mitigation measures See general directions for use 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 (2) OF THE META SPC 2 5.1. Instructions for use See ‘Use-specific instructions for use’ sections for each meta SPC. 5.2. Risk mitigation measures Engineering measures: Ensure there is sufficient ventilation of the area. All meta SPCs: Trigger spraying: only apply in rooms with a minimum ventilation rate of 20 ACH. Only for disinfection of small size surfaces. All meta SPCs: Wiping and mopping: only apply in rooms with a minimum ventilation rate of 40 ACH. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid instructions IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. Emergency measures to protect the environment Do not discharge into drains or rivers. Contain the spillage using bunding. Absorb into dry earth or sand. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer. 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 Store in a cool, well-ventilated area. Keep container tightly closed. Keep away from direct sunlight. Protect from frost. Store at temperatures not exceeding 20 °C. Shelf-life: 12 months 6\. OTHER INFORMATION — 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) | Contec CyChlor Sterile | Market area: EU ---|---|--- Authorisation number | EU-0032017-0003 1-2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) Active chlorine released from calcium hypochlorite | | Active Substance | | | 0,06 Calcium hypochlorite | Calcium hypochlorite | Releaser | 7778-54-3 | 231-908-7 | 0,092 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | Contec CyChlor | Market area: EU ---|---|--- Authorisation number | EU-0032017-0004 1-2 Common name | IUPAC name | Function | CAS number | EC number | Content (%) Active chlorine released from calcium hypochlorite | | Active Substance | | | 0,06 Calcium hypochlorite | Calcium hypochlorite | Releaser | 7778-54-3 | 231-908-7 | 0,092 META SPC 3 1\. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier Identifier | meta SPC 3 ---|--- 1.2. Suffix to the authorisation number Number | 1-3 ---|--- 1.3. Product type(s) Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- 2\. META SPC 3 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Common name | IUPAC name | Function | CAS number | EC number | Content (%) ---|---|---|---|---|--- Min | Max Active chlorine released from calcium hypochlorite | | Active Substance | | | 0,2 | 0,2 Calcium hypochlorite | Calcium hypochlorite | Releaser | 7778-54-3 | 231-908-7 | 0,31 | 0,31 2.2. Type(s) of formulation of the meta SPC 3 Formulation(s) | AL – Any other liquid ---|--- 3\. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements | May be corrosive to metals. ---|--- Precautionary statements | Keep only in original packaging. Absorb spillage to prevent material damage. 4\. AUTHORISED USE(S) OF THE META SPC 3 4.1. Use description Table 5 Use # 1 – Use 3.1 Hard surface disinfection in veterinary laboratories by trigger spray and wipe (PT 2) Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | N/A Target organism(s) (including development stage) | Common name: Bacteria Development stage: - Common name: Yeasts Development stage: - Common name: Viruses Development stage: - Field(s) of use | Indoor Disinfection of hard non-porous surfaces or equipment (excluding animal cages) by spraying followed by wiping in veterinary laboratories without pre-cleaning. Application method(s) | Method: Spraying and wiping Detailed description: The ready-to-use (RTU) product is sprayed onto a surface and distributed with a wipe. The product is applied on a hard, non-porous surface. Application rate(s) and frequency | Dilution (%): ready-to-use (RTU) product Number and timing of application: Application rate: 50 ml/m2. Contact time: 30 minutes Application frequency: Specific to the user’s site and requirements. Temperature: room temperature. Category(ies) of users | Professional Pack sizes and packaging material | RTU liquid spray packaged in 1 litre high-density polyethylene (HDPE) trigger spray bottles. 4.1.1. Use-specific instructions for use Disinfection of hard non-porous surfaces or equipment in veterinary laboratories: Apply the product by spraying the product onto the surface and distribute the product with a wipe. Ensure that the entire surface is visibly wet and that the biocidal product is uniformly distributed. Leave for the required contact time of 30 minutes for bacteria, yeast and viruses and then wipe to dry the surface. 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 Table 6 Use # 2 – Use 3.2 Hard surface disinfection in veterinary laboratories by pouring and subsequent wiping or mopping (PT 2) Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | N/A Target organism(s) (including development stage) | Common name: Bacteria Development stage: - Common name: Yeasts Development stage: - Common name: Viruses Development stage: - Field(s) of use | Indoor Disinfection of hard non-porous surfaces or equipment (excluding animal cages) by pouring followed by wiping/mopping in veterinary laboratories without pre-cleaning. Application method(s) | Method: Pouring and mopping/wiping Detailed description: Application by pouring onto a surface followed by wiping/mopping using a wipe or mop to distribute the product. Application rate(s) and frequency | Dilution (%): ready-to-use (RTU) product Number and timing of application: Application rate: 100 ml/m2 Contact time: 30 minutes Application frequency: Specific to the user’s site and requirements. Temperature: room temperature Category(ies) of users | Professional Pack sizes and packaging material | RTU liquid packaged in 700 ml, 1 litre and 5 litre capped plastic high-density polyethylene (HDPE) bottles. 4.2.1. Use-specific instructions for use Disinfection of hard non-porous surfaces or equipment in veterinary laboratories: Apply the product by pouring the product onto the surface and distribute the product with a suitable wipe or mop. Ensure that the entire surface is visibly wet and that the biocidal product is uniformly distributed. Leave for the required contact time of 30 minutes for bacteria, yeast and viruses and then wipe to dry the surface. 4.2.2. Use-specific risk mitigation measures See general directions for use 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 (3) OF THE META SPC 3 5.1. Instructions for use See ‘Use-specific instructions for use’ sections for each meta SPC. 5.2. Risk mitigation measures Engineering measures: Ensure there is sufficient ventilation of the area. All meta SPCs: Trigger spraying: only apply in rooms with a minimum ventilation rate of 20 ACH. Only for disinfection of small size surfaces. All meta SPCs: Wiping and mopping: only apply in rooms with a minimum ventilation rate of 40 ACH. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment First aid instructions IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. Emergency measures to protect the environment Do not discharge into drains or rivers. Contain the spillage using bunding. Absorb into dry earth or sand. 5.4. Instructions for safe disposal of the product and its packaging At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer. Avoid release to an individual wastewater treatment plant. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Store in a cool, well-ventilated area. Keep container tightly closed. Keep away from direct sunlight. Protect from frost. Store at temperatures not exceeding 20 °C. Shelf-life: 12 months 6\. OTHER INFORMATION — 7\. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | Contec ProChlor V | Market area: EU ---|---|--- Authorisation number | EU-0032017-0005 1-3 Common name | IUPAC name | Function | CAS number | EC number | Content (%) Active chlorine released from calcium hypochlorite | | Active Substance | | | 0,2 Calcium hypochlorite | Calcium hypochlorite | Releaser | 7778-54-3 | 231-908-7 | 0,31 * * * (1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. (2) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. (3) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3. * * * ELI: http://data.europa.eu/eli/reg_impl/2024/2175/oj ISSN 1977-0677 (electronic edition) * * *