Commission Implementing Regulation (EU) 2024/2679 of 15 October 2024 amending Implementing Regulation (EU) 2019/2076 as regards administrative and minor changes to the Union authorisation for the biocidal product family Contec IPA Product Family
Date: 2024-10-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_202402679EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2679


16.10.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2679
of 15 October 2024
         
amending Implementing Regulation (EU) 2019/2076 as regards administrative and minor changes to the Union authorisation for the biocidal product family ‘Contec IPA 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 2012 concerning the making available on the market and use of biocidal products (1) (‘the BPR’), and in particular Article 50(2) thereof,

Whereas:







(1)


On 29 November 2019, a Union authorisation with authorisation number EU-0020460-0000 was granted to Contec Europe for the making available on the market and use of the biocidal product family ‘Contec IPA Product Family’ by Commission Implementing Regulation (EU) 2019/2076 (2) (‘the authorisation’). Annex II to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for the biocidal product family ‘Contec IPA Product Family’.












(2)


Commission Implementing Regulation (EU) No 354/2013 (3) lays down rules for the different categories of changes of biocidal products sought in accordance with Article 50(2) of Regulation (EU) No 528/2012.












(3)


On 4 August 2021, Contec Europe submitted a notification to the European Chemicals Agency (the ‘Agency’) in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013 of administrative changes to the authorisation. The notification was recorded in the register for biocidal products (‘the Register’) under case number BC-QS069138-06. The notified changes concern the additions of a trade name in meta SPC 1, a manufacturer of the active substance and a manufacturer of the biocidal products and the removal of information on the carrier material in Section 6 of meta SPC 2.












(4)


On 28 February 2022, Contec Europe submitted an application to the Agency in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013 for a minor change to the authorisation. The application was recorded in the Register under case number BC-LM074066-29 and concerns an extension of the pack size range of products in meta SPC 1.












(5)


On 19 October 2021, the Agency submitted an opinion (4) to the Commission on the notified administrative changes to the authorisation, 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 regarding the additions of a trade name in meta SPC 1, a manufacturer of the active substance and a manufacturer of biocidal products are administrative changes within the meaning of 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 will still be met.












(6)


However, the Agency concluded that the change related to the removal of information on the carrier in Section 6 of meta SPC 2 is not an administrative change within the meaning of 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 should therefore be rejected.












(7)


On 9 October 2023, the Agency submitted its opinion (5) to the Commission on the application for a minor change to the authorisation, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised SPC and a revised assessment report. The opinion concluded that the proposed change is a minor change within the meaning of 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 change, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.












(8)


On 10 November 2023, the Agency transmitted to the Commission the revised SPC of the biocidal product family ‘Contec IPA Product Family’ in all official languages of the Union in accordance with Article 11(6) and Article 12(6) of Implementing Regulation (EU) No 354/2013, covering all the administrative and minor changes applied for.












(9)


The Commission concurs with the opinions of the Agency except for the assessment of the notification of an administrative change concerning the removal of information on the carrier in Section 6 of meta SPC 2. The Commission considers that the list of administrative changes in Title 1 of the Annex to Implementing Regulation (EU) No 354/2013 is not exhaustive and the notified change falls within the definition of administrative change set out in Article 3(1), point (aa), of Regulation (EU) No 528/2012. However, the Commission, having regard to the practice in the Member States, considers that the description of the nature of the carrier should remain in Section 6 of meta SPC 2 whereas the information on the active substance content and weight of the carrier should be removed. Taking this into account, the Commission considers it appropriate to amend the authorisation to introduce the administrative and minor changes requested by Contec Europe and accepted by the Commission.












(10)


Except for the accepted amendments regarding the administrative and minor changes, all other information included in the SPC of ‘Contec IPA Product Family’ as set out in Annex II to Implementing Regulation (EU) 2019/2076 remains unchanged.












(11)


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, Annex II to Implementing Regulation (EU) 2019/2076 should be replaced in its entirety.












(12)


Implementing Regulation (EU) 2019/2076 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
Annex II to Implementing Regulation (EU) 2019/2076 is replaced by the text in the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 October 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Commission Implementing Regulation (EU) 2019/2076 of 29 November 2019 granting a Union authorisation for the biocidal product family ‘Contec IPA Product Family’ ( OJ L 316, 6.12.2019, p. 19 ELI: http://data.europa.eu/eli/reg_impl/2019/2076/oj).

(3)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).

(4)  Agency Opinion of 19 October 2021 on the administrative change of the Union authorisation of the biocidal product family Contec IPA Product Family, Opinion N° UAD-C-1539242-29-00/F, https://echa.europa.eu/documents/10162/2166576/ua-adc_echa_op_contect-ipa-product-family_en.pdf/f0d3b0d1-63b6-b37b-b084-be1d4b31535b?t=1654511978949.

(5)  Biocidal Products Committee (BPC) opinion of 9 October 2023 on the minor change to the Union authorisation of the biocidal product family ‘Contec IPA Product Family’, ECHA/BPC/396/2023,

https://echa.europa.eu/documents/10162/3443008/contec_ipa_pf_ua_mic_final_bpc_opinion_en.pdf/885ca367-1d42-6402-be13-bb2f6ab49399?t=1714650903988.




ANNEX



‘ANNEX II

Summary of product characteristics for a biocidal product family

Contec IPA Product Family

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area

Authorisation number EU-0020460-0000

R4BP asset number EU-0020460-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Contec IPA Product Family




1.2.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




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-0020460-0000





R4BP asset number



 


EU-0020460-0000




Date of the authorisation


 


26 December 2019




Expiry date of the authorisation


 


30 November 2029




1.4.   Manufacturer(s) of the product







Name of manufacturer


Contec Inc.




Address of manufacturer


525 Locust Grove SC 29303 Spartanburg United States (the)




Location of manufacturing sites


Contec Inc. site 1
525 Locust Grove SC 29303 Spartanburg United States (the)













Name of manufacturer


Contec Cleanroom Technology (Suzhou) Co., Ltd. China




Address of manufacturer


17 Longyun Road, Suzhou Industrial Park 215024 Suzhou China




Location of manufacturing sites


Contec Cleanroom Technology (Suzhou) Co., Ltd. China site 1
17 Longyun Road, Suzhou Industrial Park 215024 Suzhou China













Name of manufacturer


Contec Cleanroom (UK) Ltd




Address of manufacturer


Unit 6A, Wansbeck Business Park, Rotary Parkway NE63 8QW Ashington, Northumberland United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Contec Cleanroom (UK) Ltd site 1
Unit 6A, Wansbeck Business Park, Rotary Parkway NE63 8QW Ashington, Northumberland United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Flexible Medical Packaging




Address of manufacturer


Unit 8 Hightown, White Cross Industrial Estate LA1 4XS Lancaster, Lancashire United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Flexible Medical Packaging site 1
Unit 8 Hightown, White Cross Industrial Estate LA1 4XS Lancaster, Lancashire United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


VWR International BVBA




Address of manufacturer


Researchpark Haasrode 2020, Geldenaaksebaan 464 B-3001 Leuven Belgium




Location of manufacturing sites


VWR International BVBA site 1
Researchpark Haasrode 2020, Geldenaaksebaan 464 B-3001 Leuven Belgium




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







Active substance


propan-2-ol




Name of manufacturer


Brenntag GmbH




Address of manufacturer


Messeallee 11 45131 Essen Germany




Location of manufacturing sites


Brenntag GmbH site 1
Haven 3222, Vondelingenweg 601 3196 KK Vondelingenplaat Netherlands (the)













Active substance


propan-2-ol




Name of manufacturer


INEOS Solvents Germany GmbH




Address of manufacturer


Römerstraße 733 47443 Moers Germany




Location of manufacturing sites


INEOS Solvents Germany GmbH site 1
Römerstraße 733 47443 Moers Germany




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


62,9 - 62,9 % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AL (any other liquid) – RTU wipe
AL (any other liquid) - RTU solution/trigger spray




PART II

SECOND INFORMATION LEVEL - META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


Meta SPC: Contec IPA Liquid Products




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
PT04: Food and feed area




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


62,9 - 62,9 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 1







Formulation type(s)


AL (any other liquid) - RTU solution/trigger spray




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


P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
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.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
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 present and easy to do. Continue rinsing.
P312: Call a Poison centre if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: In case of fire: Use alcohol resistant foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents/container in accordance with local regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Professional use







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




Where relevant, an exact description of the authorised use


Disinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of medical devices, healthcare industries and other critical life science applications and in industrial food and feed preparation areas.”
Acceptable use temperature: room temperature (20±2°C)




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: -
Scientific name: Mycobacteriaceae
Common name: Mycobacteria
Development stage: -
Scientific name: Yeast
Common name: Yeasts
Development stage: -




Field(s) of use


indoor use




Application method(s)


Method: Spraying and wiping
Detailed description:
-




Application rate(s) and frequency


Application rate:
50 ml product per m2 of surface.
Number and timing of application:
Wiping: 1 minute contact time for bacteria and mycobacteria
3 minutes contact time for yeast




Category(ies) of users


professional




Pack sizes and packaging material


High-density polyethylene (HDPE) trigger spray bottle – 0,5 litre – 1 litre
HDPE capped refill bottle - 1 litre, 2 litres and 5 litres




4.1.1.   Use-specific instructions

See section 5.1
4.1.2.   Use-specific risk mitigation measures

See section 5.2
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 section 5.3
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See section 5.4
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See section 5.5
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

Use at room temperature. For visibly soiled surfaces, cleaning prior to disinfection is required.
Wiping: Apply/Spray product to a suitable quality cleanroom wipe. Ensure the wipe is sufficiently and uniformly saturated before wiping the surface to be disinfected.
Ensure the surface is uniformly covered with the product then wipe to dry with a sterile cleanroom wipe.
Contact times: Wiping 1 minute for bacteria and mycobacteria 3 minutes for yeast.
Used wipes must be disposed of in a closed container.
5.2.   Risk mitigation measures

Wash hands and exposed skin before meals and after use.
Avoid contact with eyes
For use in cleanrooms, adequate technical/engineering controls to remove airborne residues is mandatory e.g. room ventilation or LEV
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect adverse effects:
Headache, vertigo, hallucinations, respiratory depression, CNS depression or coma.
Severe irritation of the eyes and or ocular damage.
Nausea, vomiting, diarrhea and hemorrhagic gastritis.
Pulmonary aspiration hazard may induce pneumonitis, hypotension and hypoglycemia.
First aid measures:
Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.
Eye contact: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention
Skin contact; wash affected area with plenty of water and soap, No scrubbing.
In case of ingestion; Do NOT induce vomiting and never give anything by mouth to an impaired or unconscious individual; if the individual is unconscious place individual in left sideways (recovery) position with the head lowered and the knees bent.
Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.
Take the individual to a healthcare center and bring packaging or label whenever possible.
NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
Advice for medical and healthcare personnel:
Monitor vital signs and provide symptomatic and supportive treatment.
Evaluate endoscopic procedure in case of ingestion.
Monitor glycaemia and ketones.
Ipecac use is contraindicated.
WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER 111.
5.4.   Instructions for safe disposal of the product and its packaging

Dispose of contents/container in accordance with local regulations.
Do not re-use empty container for any other purpose.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store in a cool, dry, well-ventilated place in original container.
Keep away from sources of ignition.
Keep away from direct sunlight.
Keep container tightly closed.
Shelf-life: 2 years
6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No: 67-63-0), for which an 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)


Contec IPA


Market area: EU




Contec Sterile IPA


Market area: EU




Ipasept


Market area: EU




Authorisation number


 


EU-0020460-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




propan-2-ol


 


active substance


67-63-0


200-661-7


62,9 % (w/w)




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC: Contec IPA Wipes




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
PT04: Food and feed area




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 (%)




propan-2-ol


 


active substance


67-63-0


200-661-7


62,9 - 62,9 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 2







Formulation type(s)


AL (any other liquid) – RTU wipe




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







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


P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
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.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
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 present and easy to do. Continue rinsing.
P312: Call a POISON CENTER if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: In case of fire: Use alcohol resistant foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to container in accordance with local regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Professional use







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




Where relevant, an exact description of the authorised use


Disinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of medical devices, healthcare industries and other critical life science applications and in industrial food and feed preparation areas.”
Acceptable use temperature: room temperature (20±2°C)




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: -
Scientific name: Mycobacteriaceae
Common name: Mycobacteria
Development stage: -
Scientific name: Yeast
Common name: Yeasts
Development stage: -




Field(s) of use


indoor use




Application method(s)


Method: Wiping
Detailed description:
-




Application rate(s) and frequency


Application rate:
-
Number and timing of application:
1 minute contact time for bacteria and mycobacteria
3 minutes contact time for yeast




Category(ies) of users


professional




Pack sizes and packaging material


Impregnated 100 % polypropylene wipes in:






—


HDPE canister with HDPE cap – 150 wipes (1,7 or 2,15 L)










—


Polyethylene terephthalate ( PET)/polyethylene (PE) packet sealed with PET/PE flow wrap – 30, 40 or 50 wipes




Impregnated 100 % polyester wipes in:






—


HDPE canister with HDPE cap – 100 wipes (2,25 L)










—


PET/PE packet sealed with PET/PE flow wrap – 20 wipes




Impregnated 100 % knitted polyester wipes in:






—


PET/PE packet sealed with PET/PE flow wrap – 8, 10, 20, 30 or 50 wipes




Impregnated 55 % cellulose / 45% polyester wipes in:






—


HDPE canister with HDPE cap – 100 wipes (2,25 L)










—


PET/PE packet sealed with PET/PE flow wrap – 24, 30, 50 or 75 wipes




Impregnated 50 % rayon / 50% polyester wipes in:






—


HDPE canister with HDPE cap - 700 wipes (11,4 L)








4.1.1.   Use-specific instructions

See section 5.1
4.1.2.   Use-specific risk mitigation measures

See section 5.2
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 section 5.3
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See section 5.4
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See section 5.5
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

For soiled surfaces, cleaning prior to disinfection is required.
Ensure the surface is uniformly covered with the product, allow to act for a contact time of 1 minute for bactericidal and mycobactericidal action and 3 minutes for yeasticidal action.
5.2.   Risk mitigation measures

Wash hands and exposed skin before meals and after use.
Avoid contact with eyes
For use in cleanrooms, adequate technical/engineering controls to remove airborne residues is mandatory e.g. room ventilation or LEV
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect adverse effects:
Headache, vertigo, hallucinations, respiratory depression, CNS depression or coma.
Severe irritation of the eyes and or ocular damage.
Nausea, vomiting, diarrhea and hemorrhagic gastritis.
Pulmonary aspiration hazard may induce pneumonitis, hypotension and hypoglycemia.
First aid measures:
Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.
Eye contact: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention
Skin contact; wash affected area with plenty of water and soap, No scrubbing.
In case of ingestion; Do NOT induce vomiting and never give anything by mouth to an impaired or unconscious individual; if the individual is unconscious place individual in left sideways (recovery) position with the head lowered and the knees bent.
Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.
Take the individual to a healthcare center and bring packaging or label whenever possible.
NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
Advice for medical and healthcare personnel:
Monitor vital signs and provide symptomatic and supportive treatment.
Evaluate endoscopic procedure in case of ingestion.
Monitor glycaemia and ketones.
Ipecac use is contraindicated.
WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER 111
5.4.   Instructions for safe disposal of the product and its packaging

Dispose of contents/container in accordance with local regulations.
Do not re-use empty container for any other purpose.
Used wipes must be disposed in a closed container
Dispose of used wipes by dry waste to landfill
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store in a cool, dry, well-ventilated place in original container.
Keep away from sources of ignition.
Keep away from direct sunlight.
Keep container tightly closed.
Shelf-life: 2 years
6.   OTHER INFORMATION

Polypropylene, polyester, kitted polyester, 55 % cellulose / 45 % polyester or 50 % rayon / 50 % polyester wipes.
The product contains propan-2-ol (CAS No: 67-63-0), for which an 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 2

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













Trade name(s)


PROSAT EasyReach


Market area: EU




PROSAT Sterile EasyReach


Market area: EU




PROSAT Wipes


Market area: EU




PROSAT Sterile Wipes


Market area: EU




SATWipes Wipes


Market area: EU




SATWipes Sterile Wipes


Market area: EU




Cleanroom wipes, presaturated Spec-Wipe


Market area: EU




Authorisation number


 


EU-0020460-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




propan-2-ol


 


active substance


67-63-0


200-661-7


62,9 % (w/w)






            ’
         



ELI: http://data.europa.eu/eli/reg_impl/2024/2679/oj
ISSN 1977-0677 (electronic edition)