Commission Implementing Regulation (EU) 2021/1322 of 3 August 2021 amending Implementing Regulation (EU) 2019/2076 to make administrative changes to the Union authorisation of the biocidal product family ‘Contec IPA Product Family’ (Text with EEA relevance)
Date: 2021-08-03
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: chemical product, decontamination, market approval








L_2021288EN.01000101.xml










11.8.2021   


EN


Official Journal of the European Union


L 288/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2021/1322
of 3 August 2021
         
amending Implementing Regulation (EU) 2019/2076 to make administrative changes to the Union authorisation of 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), and in particular the first subparagraph of Article 44(5) and Article 50(2) thereof,

Whereas:







(1)


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












(2)


On 5 February 2020, Contec Europe submitted a notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), regarding the administrative changes to the Union authorisation for the biocidal product family ‘Contec IPA Product Family’ as referred to in Section 1 of Title 1 of the Annex to that Regulation.












(3)


Contec Europe proposed the revision of the list of product trade names, including the changes in the trade names and the removal of the trade names of the individual products in the meta SPCs 1 and 2, of the summary of the product characteristics for the biocidal product family ‘Contec IPA Product Family’ as set out in Annex II to Implementing Regulation (EU) 2019/2076. The notification was recorded under the case number BC-GC057245-55 in the Register for Biocidal Products.












(4)


On 6 March 2020, the Agency submitted an opinion (4) on the proposed changes to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder fall under Article 50(3)(a) of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 of that Regulation are still met. On the same date, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.












(5)


The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family ‘Contec IPA Product Family’.












(6)


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
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, 3 August 2021.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(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).

(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).

(4)  ECHA opinion of 2 March 2020 on the administrative change of the Union authorisation of the biocidal product family ‘Contec IPA Product Family’, https://echa.europa.eu/documents/10162/22836226/opinion_for_ua_admin_change_bc-gc057245-55_en.pdf/b848e01c-b8bb-41ac-4dff-650cbfd33ff9




ANNEX



‘ANNEX II
Summary of product characteristics for a biocidal product family
Contec IPA Product Family
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
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 (Disinfectants)
PT04 – Food and feed area (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-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 biocidal products







Name of manufacturer


Contec Inc.




Address of manufacturer


525 Locust Grove, SC 29303 Spartanburg United States




Location of manufacturing sites


525 Locust Grove, SC 29303 Spartanburg United States













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


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




Location of manufacturing sites


Unit 6A, Wansbeck Business Park, Rotary Parkway, NE63 8QW Ashington, Northumberland United Kingdom













Name of manufacturer


Flexible Medical Packaging




Address of manufacturer


Unit 8 Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom




Location of manufacturing sites


Unit 8 Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom




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


Haven 3222, Vondelingenweg 601, 3196 KK Vondelingenplaat Netherlands




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




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,9


62,9




2.2.   Type(s) of formulation







Formulation(s)


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




PART II

SECOND INFORMATION LEVEL – META SPC(S)


META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 1 identifier







Identifier


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 (Disinfectants)
PT04 – Food and feed area (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




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,9


62,9




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







Formulation(s)


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




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1






Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Wash hands thoroughly after handling.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Call a Poison centre if you feel unwell.
If eye irritation persists: Get medical advice.
In case of fire: Use alcohol resistant foam to extinguish.
Store in a well-ventilated place. Keep cool.
Store locked up.
Dispose of contents/container in accordance with local regulations.




4.   AUTHORISED USE(S) OF THE META SPC 1
4.1.   Use description


Table 1


Use # 1 – Professional use







Product type


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




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Bacteria
Mycobacteria
Yeasts




Field(s) of use


Indoor
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)




Application method(s)


Spraying and wiping




Application rate(s) and frequency


50 ml product per m2 of surface.
Wiping: 1 minute contact time for bacteria and myobacteria
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 L – 1 L
HDPE capped refill bottle – 5 L




4.1.1.   Use-specific instructions for use

See general directions for use
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 (1) 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, diarrhoea and haemorrhagic gastritis.









Pulmonary aspiration hazard may induce pneumonitis, hypotension and hypoglycaemia.




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 centre 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 CENTRE ☐ [INSERT LOCAL NUMBER HERE].
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
Contec Sterile IPA




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





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 2 identifier







Identifier


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 (Disinfectants)
PT04 – Food and feed area (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




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,9


62,9




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







Formulation(s)


AL (any other liquid) – RTU wipe




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2






Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Wash hands thoroughly after handling.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTRE if you feel unwell.
If eye irritation persists: Get medical advice.
In case of fire: Use alcohol resistant foam to extinguish.
Store in a well-ventilated place. Keep cool.
Store locked up.
Dispose of contents/container in accordance with local regulations.




4.   AUTHORISED USE(S) OF THE META SPC 2
4.1.   Use description


Table 2


Use # 1 – Professional use







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Bacteria
Mycobacteria
Yeasts




Field(s) of use


Indoor
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)




Application method(s)


Wiping




Application rate(s) and frequency


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 L 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 for use

See general directions for use
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 (2) 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, diarrhoea and haemorrhagic gastritis.









Pulmonary aspiration hazard may induce pneumonitis, hypotension and hypoglycaemia.




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 centre 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 CENTRE ☐ [INSERT LOCAL NUMBER HERE].
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, 34-240 gsm, containing 5 – 38 ml product (2,75 – 20,9 g propan-2-ol)
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
PROSAT Sterile EasyReach
PROSAT Wipes
PROSAT Sterile Wipes
SATWipes Wipes
SATWipes Sterile Wipes
Cleanroom wipes, presaturated Spec-Wipe




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






            ’
         


(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.