Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2024/1752 25.6.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/1752 of 24 June 2024 amending Implementing Regulation (EU) 2021/552 as regards administrative and minor changes to the Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’ (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the...
Official Journal EN of the European Union L series 2024/1752 25.6.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/1752 of 24 June 2024 amending Implementing Regulation (EU) 2021/552 as regards administrative and minor changes to the Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’ (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012concerning the making available on the market and use of biocidal products(1), and in particular Article 50(2) thereof,
Whereas:
(1) On 30 March 2021, a Union authorisation with authorisation number EU-0024324-0000 was granted to Veltek Associates Inc. Europe for the making available on the market and use of the biocidal product family ‘DEC-AHOL® Product Family’ by Commission Implementing Regulation (EU) 2021/552(2). The Annex to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for the biocidal product family ‘DEC-AHOL® Product Family’ in accordance with Article 22 of Regulation (EU) No 528/2012.
(2) Commission Implementing Regulation (EU) No 354/2013(3) lays down the procedural rules for the different categories of changes referred to in Article 50(3) of Regulation (EU) No 528/2012. On receipt of an opinion from the European Chemicals Agency (‘the Agency’) on an application from an authorisation holder of a Union authorisation seeking to change any of the information submitted for the initial application for authorisation, the Commission is to decide whether the conditions of Article 19 or, where relevant, Article 25 of Regulation (EU) No 528/2012, are still met and whether the terms and conditions of the authorisation are required to be amended.
(3) On 29 June 2022, Veltek Associates Inc. Europe submitted to the Agency a notification of administrative changes to the Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’, in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013, recorded in the register for biocidal products (‘the Register’) under case number BC-WR078024-12. The notified changes regarded the addition of two active substance manufacturers.
(4) On 9 August 2023, Veltek Associates Inc. Europe submitted to the Agency an application for minor changes to the Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’ in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, recorded in the Register under case number BC-HJ088175-32, for changes in the instructions for uses of meta SPCs 2, 3 and 4, an increase of the shelf-life and a change in the pack size range of products in meta SPC 1.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2021/552 of 30 March 2021 granting a Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’ (OJ L 111, 31.3.2021, p. 13, ELI: http://data.europa.eu/eli/reg_impl/2021/552/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).
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 1/27EN OJ L, 25.6.2024
(5) On 11 August 2022, the Agency submitted an opinion(4)to the Commission on the notified administrative changes to the Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, together with a revised SPC. The opinion concludes that the proposed changes are administrative changes in accordance with Article 3(1), point (aa), of Regulation (EU) No 528/2012 and as specified in Title 1 of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 are still met.
(6) On 9 January 2024, the Agency submitted its opinion(5)to the Commission on the application for minor changes to the Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised SPC and a revised assessment report. This opinion concluded that the proposed changes are minor changes in accordance with Article 3(1), point
(ab), of Regulation (EU) No 528/2012 and as specified in Title 2 of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 are still met.
(7) On 6 February 2024, the Agency transmitted to the Commission the revised SPC of the Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’ in all official languages of the Union covering the administrative and minor changes applied for, in accordance with Article 11(6) and Article 12(6) of Implementing Regulation (EU) No 354/2013.
(8) The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’ to introduce the administrative and minor changes requested by Veltek Associates Inc. Europe.
(9) Except for the amendments regarding the administrative and minor changes, all other information included in the SPC of ‘DEC-AHOL® Product Family’ as set out in the Annex to Implementing Regulation (EU) 2021/552 remains unchanged.
(10) In order to enhance clarity and to ease the access of users and interested parties to the final consolidated version of the SPC which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2021/552 should be replaced in its entirety.
(11) Implementing Regulation (EU) 2021/552 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1 The Annex to Implementing Regulation (EU) 2021/552 is replaced by the text in the Annex to this Regulation.
(4) European Chemicals Agency (ECHA) opinion on the administrative change to the Union authorisation of the biocidal product family ‘DEC-AHOL® Product Family of 11 August 2022, Opinion N° UAD-C-1599800-27-00/F, f6d20bc5-5822-02d9-2800-006583f0128d (europa.eu)
(5) Biocidal Products Committee (BPC) opinion on the minor change to the Union authorisation of the biocidal product family ‘DEC- AHOL® Product Family of 9 January 2024, ECHA/BPC/410/2024, https://echa.europa.eu/opinions-on-union-authorisation 2/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024 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, 24 June 2024.
For the Commission The President Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 3/27EN OJ L, 25.6.2024 ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY DEC-AHOL® Product Family Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals Authorisation number EU-0024324-0000 R4BP asset number EU-0024324-0000 PART I.
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name Name DEC-AHOL® Product Family
1.2. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals
1.3. Authorisation holder Name Veltek Associates Inc. Europe Name and address of the authorisation holder Address Rozengaard 1940 8212DT Lelystad NL Authorisation number EU-0024324-0000 R4BP asset number EU-0024324-0000 Date of the authorisation 20 April 2021 Expiry date of the authorisation 31 March 2031
1.4. Manufacturer(s) of the product Name of manufacturer Veltek Associates, Inc., Address of manufacturer 15 Lee Blvd. PA19355 Malvern United States (the) Location of manufacturing sites 15 Lee Blvd. PA19355 Malvern United States (the) 4/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024
1.5. Manufacturer(s) of the active substance(s) Active substance Propan-2-ol Name of manufacturer Exxon Mobil Chemical Company Address of manufacturer 4045 Scenic Hwy, Baton Rouge, LA 70805 Louisiana United States (the) Location of manufacturing sites Exxon Mobil Chemical Company site 1 4045 Scenic Hwy, Baton Rouge, LA 70805 Louisiana United States (the) Active substance Propan-2-ol Name of manufacturer Monument Chemical Houston, LTD Address of manufacturer 16717 Jacintoport Boulevard 77015 Houston United States (the) Location of manufacturing sites Monument Chemical Houston, LTD site 1 16717 Jacintoport Boulevard 77015 Houston United States (the) Active substance Propan-2-ol Name of manufacturer Shell Chemicals Address of manufacturer 150 St Claire Parkway ON N0N 1G0 Corunna Canada Location of manufacturing sites Shell Chemicals site 1 150 St Claire Parkway ON N0N 1G0 Corunna Canada
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 (%) Propan-2-ol active substance 67-63-0 200-661-7 64,8- 65,4% (w/ w)
2.2. Type(s) of formulation Formulation type(s) AE Aerosol dispenser AL Any other liquid XX others - RTU wipe
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 5/27EN OJ L, 25.6.2024 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) PT02: Disinfectants and algaecides not intended for direct application to humans or animals
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 (%) Propan-2-ol active substance 67-63-0 200-661-7 65,4- 65,4% (w/ w)
2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s) XX other - RTU wipe
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statements H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
6/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024 P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if pre sent and easy to do. Continue rinsing.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P403+P233: Store in a well-ventilated place. Keep con tainer tightly closed.
P405: Store locked up.
P501: Dispose of contents to in accordance with local/ national regulations.
P280: Wear eye protection.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description Table 1.
1.1 Disinfection of hard non-porous surfaces; Wipes (individual wipes and multi-pack wipes) Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: no data stage) Common name: Bacteria
Development stage: -
Scientific name: no data
Common name: yeast
Development stage: - Field(s) of use indoor use Disinfectant wipe for use in cleanrooms of pharmaceutical, biophar maceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.
Application method(s) Method: Wiping of surfaces
Detailed description: - Application rate(s) and frequency Application rate: - Dilution (%): RTU
Number and timing of application:
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 7/27EN OJ L, 25.6.2024 Product may be used multiple times a day, if required.
Contact time: 2 min
Individual wipes:
15.2 cm x 15.2 cm wipe - 4 wipes per m2
30.5 cm x 30.5 cm wipe - 1 wipe per m2
45.7 cm x 45.7 cm wipe - 1 wipe per m2
Multi pack wipes:
23 cm x 23 cm - 2 wipes per m2
30.5 cm x 30.5 cm - 1 wipe per m2 Category(ies) of users industrial Pack sizes and packaging material Pre-saturated 65.4% w/w propan-2-ol and water for injection (WFI) wipes.
Individual wipes A wipe is composed of 100% continuous filament polyester fibre. The wipes are packaged in individual heat-sealed plastic bags made of low density polyethylene.
Pack sizes:
15.2 cm x 15.2 cm wipe - 100/case, non- sterile
15.2 cm x 15.2 cm wipe - 100/case, sterile
30.5 cm x 30.5 cm wipe - 100/case, sterile
45.7 cm x 45.7 cm wipe - 100/case, sterile Multi pack wipes A wipe is composed of 100% continuous filament knitted polyester fibre; 20 wipes per pack; folded together in a re-closable bag package.
Pack sizes:
100% polyester 30.5 cm x 30.5 cm wipe - 200/case, non-sterile 100% polyester 30.5 cm x 30.5 cm wipe - 200/case, sterile 100% polyester 23 cm x 23 cm wipe - 200/case, sterile
4.1.1. Use-specific instructions Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to Good Manufacturing Practice (GMP) EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Only use wet wipes. Remove one or two wipes at a time for individual wipes and one wipe at a time for multipack wipes. Make sure to wet surfaces completely. Allow to take effect for at least 2 minutes. Discard wipe after use in a closed container and for multipack wipes close the package after opening.
Individual wipes:
15.2 cm x 15.2 cm wipe - 4 wipes per m2
30.5 cm x 30.5 cm wipe - 1 wipe per m2
45.7 cm x 45.7 cm wipe - 1 wipe per m2 8/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024
Multi pack wipes:
30.5 cm x 30.5 cm - 1 wipe per m2 23 cm x 23 cm wipe - 2 wipes per m2
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.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use See use-specific instructions for use.
5.2. Risk mitigation measures Use adequate ventilation with an air change rate of 8 per hour or more.
Apply away from eyes and face.
Hand protection: Wear chemically resistant protective gloves.
Eye protection: Wear eye protection.
Avoid contact with eyes.
Do not breathe vapours.
Do not eat, drink or smoke when using the product.
Wash hands thoroughly after handling.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Symptoms/injuries after inhalation : May cause drowsiness or dizziness Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
Symptoms/injuries after eye contact: Causes serious eye irritation Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 9/27EN OJ L, 25.6.2024
IF ON SKIN: Rinse skin with water/ or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
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
IF SWALLOWED: Rinse mouth. Give something to drink if conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
5.4. Instructions for safe disposal of the product and its packaging Empty containers must be discharged as normal waste or recycled where possible.
Additional information: Handle empty containers with care because residual vapours are flammable.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Keep in a cool, well-ventilated place. Keep away from open flames, hot surfaces and sources of ignition. Store at temperatures below 30°C.
Shelf-life: 3 years
6. OTHER INFORMATION The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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) ALCOH-WIPE® Market area: EU PROCESS2WIPE® Market area: EU IPA70 Authorisation number EU-0024324-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol active 67-63-0 200-661-7 65,4 sub stance
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
Identifier Meta SPC: Meta SPC 2 10/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024
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
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common name UPAC name Function CAS number EC number Content (%) Propan-2-ol active substance 67-63-0 200-661-7 64,8- 64,8% (w/ w)
2.2. Type(s) of formulation of the meta SPC 2 Formulation type(s) AE Aerosol dispenser
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 Hazard statements H222 : Extremely flammable aerosol, H229 : Pressurised
container: May burst if heated H229: Pressurised container: May burst if heated H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P211: Do not spray on an open flame or other ignition source.
P251: Do not pierce or burn, even after use.
P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 11/27EN OJ L, 25.6.2024 P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if pre sent and easy to do. Continue rinsing.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P403+P233: Store in a well-ventilated place. Keep con tainer tightly closed.
P405: Store locked up.
P410+P412: Protect from sunlight. Do no expose to temperatures exceeding 50°C/ 122°F.
P501: Dispose of contents to in accordance with local/ national regulations.
P280: Wear eye protection.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description Table 1.
2.1 Disinfection of hard non-porous surfaces in cleanrooms; Aerosols (propellant) Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: no data stage) Common name: Bacteria
Development stage: -
Scientific name: no data
Common name: yeast
Development stage: - Field(s) of use indoor use Disinfectant for use in cleanrooms of pharmaceutical, biopharma ceutical, medical device and diagnostic product manufacturing facil ities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.
Application method(s) Method: Aerosol spraying on surfaces
Detailed description: - 12/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024 Application rate(s) and frequency Application rate: Maximal application 35 ml/m2 Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required.
Apply product by spraying from 15-20 cm distance for 20 seconds/ m2.
Contact time: 1 minute Category(ies) of users industrial Pack sizes and packaging material 325 ml (11 oz) - aerosol can (aluminium coated on the inside with epoxy phenolic resin)
4.1.1. Use-specific instructions Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Spray the surface to be disinfected from a distance of 15-20 cm.
Thoroughly wet surface with product for 20 seconds/m2, make sure to wet surfaces completely. Allow to take effect for at least 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe. Clothes or wipes treated with the product must be discarded in a closed container.
4.1.2. Use-specific risk mitigation measures Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
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.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use See use-specific instructions for use.
5.2. Risk mitigation measures Use adequate ventilation with an air change rate of 8 per hour or more.
Apply away from eyes and face.
Hand protection: Wear chemically resistant protective gloves.
Eye protection: Wear eye protection.
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 13/27EN OJ L, 25.6.2024 Avoid contact with eyes.
Do not breathe vapours.
Do not eat, drink or smoke when using the product.
Wash hands thoroughly after handling.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Symptoms/injuries after inhalation : May cause drowsiness or dizziness Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
Symptoms/injuries after eye contact: Causes serious eye irritation Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Rinse skin with water/or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
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
IF SWALLOWED: Rinse mouth. Give something to drink if conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
5.4. Instructions for safe disposal of the product and its packaging Empty containers must be discharged as normal waste or recycled where possible.
Additional information: Handle empty containers with care because residual vapours are flammable.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep away from open flames, hot surfaces and sources of ignition.
Keep container tightly closed. Keep in a cool, well-ventilated place. Store at temperatures below 40°C. Protect from frost.
Shelf-life: 3 years
6. OTHER INFORMATION The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129.28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
14/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024
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) DEC-AHOL® Market area: EU AEROSOL WFI Formula Authorisation number EU-0024324-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol active 67-63-0 200-661-7 64,8 sub stance
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
Identifier Meta SPC: 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
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 (%) Propan-2-ol active substance 67-63-0 200-661-7 65,4- 65,4% (w/ w)
2.2. Type(s) of formulation of the meta SPC 3 Formulation type(s) AL Any other liquid
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 15/27EN OJ L, 25.6.2024
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 Hazard statements H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if pre sent and easy to do. Continue rinsing.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local/ national regulations.
P261: Avoid breathing spray.
P280: Wear eye protection.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description Table 1
3.1 Disinfection of hard non-porous surfaces in cleanrooms; Trigger Spray, Liquid Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the - authorised use 16/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024 Target organism(s) (including development Scientific name: no data stage) Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: yeast
Development stage: - Field(s) of use indoor use Disinfectant for use in cleanrooms of pharmaceutical, biopharma ceutical, medical device and diagnostic product manufacturing facil ities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.
Application method(s) Method: Trigger Spraying on surfaces
Detailed description: - Application rate(s) and frequency Application rate: Maximal application 35 ml/m2 Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required.
Apply product by spraying from 15-20 cm distance. Use 40 squeezes/m2
Contact time: 1 minute Category(ies) of users industrial
Pack sizes and packaging material Trigger:
473 ml (16 oz) - trigger spray - 12/case, sterile 946 ml (32 oz) - trigger spray - 12/case, sterile 473 ml (16 oz) - trigger spray - 12/case, non-sterile 946 ml (32 oz) - trigger spray - 12/case, non-sterile Bottles are made of high density polyethylene, the dip tube is poly propylene. The bottle cap is polypropylene, the induction seal is polypropylene. Bottles are provided with a polyethylene sprayer already on the bottle or provided separately for customer to put on themselves. If triggers are not installed, a polyethylene screw cap is supplied on the bottles. Bottles are individually triple bagged in cardboard boxes. The product is only supplied to the users in sealed cases.
Bag in bottle- Trigger:
500 ml (16 oz)– Bag in bottle trigger spray - 12/case, sterile 1000 ml (32 oz) - Bag in bottle trigger spray - 12/case, sterile
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 17/27EN OJ L, 25.6.2024 Bottles are made of high density polyethylene, they are provided with a polyethylene sprayer already on the bottle, the dip tube is polypro pylene. The bag inside the bottle is Surlyn® (thermoplastic resins).
Bottles are individually triple bagged in cardboard boxes. The product is only supplied to the users in sealed cases.
4.1.1. Use-specific instructions Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Direct the spray onto the surface from a distance of 15-20 cm. Make sure to wet the surface completely (40 squeezes/m2). Allow to take effect for at least 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe, if necessary. Only small surfaces may be disinfected. Cloths or wipes treated with the product must be discarded in a closed container.
4.1.2. Use-specific risk mitigation measures Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
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.
3.2 Disinfection of hard non-porous surfaces (including floors) in cleanrooms; Wiping Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: no data stage) Common name: Bacteria
Development stage: -
Scientific name: no data
Common name: yeast
Development stage: - 18/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024 Field(s) of use indoor use Disinfectant for use in cleanrooms of pharmaceutical, biopharma ceutical, medical device and diagnostic product manufacturing facil ities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.
Application method(s) Method: Wetting of sterile wipe/cloth prior to wiping of surface
Detailed description: - Application rate(s) and frequency Application rate: Maximal application 35 ml/m2 Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required.
Contact time: 1 minute.
Category(ies) of users industrial
Pack sizes and packaging material Squeeze bottle:
473 ml (16 oz) – squeeze individually bagged- 12/case, sterile 473 ml (16 oz) – squeeze, bulk group in one large bag – 12/case, sterile. Bulk pack bottles are not individually bagged.
Bottle is made of low density polyethylene
Drum or bottle:
18.9 litre (5 gallon drum) - container double bagged- 1/case, sterile
3.79 litre (1 gallon bottle) – each container double bagged- 4/case, sterile
3.79 litre (1 gallon bottle) – each container double bagged- 4/case, non-sterile
4.2.1. Use-specific instructions Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Thoroughly wet a sterile wipe/cloth with the product, make sure to wet the surfaces completely. Allow to take effect for at least 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe, if necessary. Only small surfaces may be disinfected.
Cloths or wipes treated with the product must be discarded in a closed container.
4.2.2. Use-specific risk mitigation measures Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 19/27EN OJ L, 25.6.2024
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.
4.3. Use description Table 3.
3.3 Disinfection of cleanroom gloves Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: no data stage) Common name: Bacteria
Development stage: -
Scientific name: no data
Common name: yeast
Development stage: - Field(s) of use indoor use Disinfectant for use on gloved hands in cleanrooms of pharmaceuti cal, biopharmaceutical, medical device and diagnostic product man ufacturing facilities.
Application method(s) Method: Dispensing of liquid droplets on gloves
Detailed description: - Application rate(s) and frequency Application rate: 1.5 ml per glove Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required.
Contact time: 1 minute.
Category(ies) of users industrial Pack sizes and packaging material 946 ml (32 oz) bottle - 12/case, sterile 946 ml (32 oz) bottle - 12/case, non-sterile The bottle is low density polyethylene
4.3.1. Use-specific instructions Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
20/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024 Hold gloved hands under spout sensor to catch liquid. Thoroughly rub to distribute liquid evenly and wet clean glove surfaces with product. Do not wipe off and allow to remain wet for a minimum of 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe, if necessary.
Cloths or wipes treated with the product must be discarded in a closed container.
Do not use on bare hands.
4.3.2. Use-specific risk mitigation measures Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
4.3.3. 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.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use.
4.3.5. 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 3
5.1. Instructions for use See use-specific instructions for use.
5.2. Risk mitigation measures Use adequate ventilation with an air change rate of 8 per hour or more.
Apply away from eyes and face.
Hand protection: Wear chemically resistant protective gloves.
Eye protection: Wear eye protection.
Avoid contact with eyes.
Do not breathe vapours.
Do not eat, drink or smoke when using the product.
Wash hands thoroughly after handling.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Symptoms/injuries after inhalation : May cause drowsiness or dizziness Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
Symptoms/injuries after eye contact: Causes serious eye irritation Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 21/27EN OJ L, 25.6.2024
IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Rinse skin with water/or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
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
IF SWALLOWED: Rinse mouth. Give something to drink if conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
5.4. Instructions for safe disposal of the product and its packaging Empty containers must be discharged as normal waste or recycled where possible.
Additional information: Handle empty containers with care because residual vapours are flammable.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep container tightly closed. Keep in a cool, well-ventilated place. Keep away from open flames, hot surfaces and sources of ignition. Store at temperatures below 40°C.
Protect from frost.
Shelf-life : 3 years
6. OTHER INFORMATION The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129.28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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) DEC-AHOL® WFI Market area: EU Formula DEC-AHOL® Market area: EU ASEPTI-CLEANSE Authorisation number EU-0024324-0003 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol active sub 67-63-0 200-661-7 65,4 stance 22/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
Identifier Meta SPC: Meta SPC 4
1.2. Suffix to the authorisation number Number 1-4
1.3. Product type(s) Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals
2. META SPC 4 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 4 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol active substance 67-63-0 200-661-7 65,4- 65,4% (w/ w)
2.2. Type(s) of formulation of the meta SPC 4 Formulation type(s) AE Aerosol dispenser
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 Hazard statements H222 : Extremely flammable aerosol, H229 : Pressurised
container: May burst if heated H229: Pressurised container: May burst if heated H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P211: Do not spray on an open flame or other ignition source.
P251: Do not pierce or burn, even after use.
P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 23/27EN OJ L, 25.6.2024 P280: Wear protective gloves.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if pre sent and easy to do. Continue rinsing.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P403+P233: Store in a well-ventilated place. Keep con tainer tightly closed.
P405: Store locked up.
P410+P412: Protect from sunlight. Do no expose to temperatures exceeding 50°C/ 122°F.
P501: Dispose of contents to in accordance with local/ national regulations.
P280: Wear eye protection.
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description Table 1.
4.1 Disinfection of hard non-porous surfaces in cleanrooms; Aerosols Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: no data stage) Common name: Bacteria
Development stage: -
Scientific name: no data
Common name: yeast
Development stage: - Field(s) of use indoor use Disinfectant for use in cleanrooms of pharmaceutical, biopharma ceutical, medical device and diagnostic product manufacturing facil ities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.
24/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024 Application method(s) Method: Aerosol spraying on surfaces
Detailed description: - Application rate(s) and frequency Application rate: Maximal application 35 ml/m2 Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required. Apply product by spraying from 15-20 cm distance for 20 seconds/m2.
Contact time: 1 minute Category(ies) of users industrial Pack sizes and packaging material 325 ml (11 oz) – Inverta-Spray® mist spray Aluminium coated inside with epoxy phenolic resin fitted with low density polyethylene bag liner (bag-on-valve), compressed air pro pellant.
4.1.1. Use-specific instructions Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Spray the surface to be disinfected from a distance of 15-20 cm.
Thoroughly wet surface with product for 20 seconds/m2, make sure to wet surfaces completely. Allow to take effect for at least 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe. Cloths or wipes treated with the product must be discarded in a closed container.
4.1.2. Use-specific risk mitigation measures Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
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.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
5.1. Instructions for use See use-specific instructions for use.
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 25/27EN OJ L, 25.6.2024
5.2. Risk mitigation measures Use adequate ventilation with an air change rate of 8 per hour or more.
Apply away from eyes and face.
Hand protection: Wear chemically resistant protective gloves.
Eye protection: Wear eye protection.
Avoid contact with eyes.
Do not breathe vapours.
Do not eat, drink or smoke when using the product.
Wash hands thoroughly after handling.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment Symptoms/injuries after inhalation : May cause drowsiness or dizziness Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
Symptoms/injuries after eye contact: Causes serious eye irritation Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Rinse skin with water or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
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
IF SWALLOWED: Rinse mouth. Give something to drink if conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
5.4. Instructions for safe disposal of the product and its packaging Empty containers must be discharged as normal waste or recycled where possible.
Additional information: Handle empty containers with care because residual vapours are flammable.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Keep away from open flames, hot surfaces and sources of ignition.
Keep container tightly closed. Keep in a cool, well-ventilated place. Store at temperatures below 40°C. Protect from frost.
Shelf-life: 3 years 26/27 ELI: http://data.europa.eu/eli/reg_impl/2024/1752/ojEN OJ L, 25.6.2024
6. OTHER INFORMATION The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129.28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) DEC-AHOL® AEROSOL Market area: EU WFI Formula Invertaspray Authorisation number EU-0024324-0004 1-4 Common name IUPAC name Function CAS EC number Content (%) number Propan-2-ol active substance 67-63-0 200-661-7 65,4
ELI: http://data.europa.eu/eli/reg_impl/2024/1752/oj 27/27