Commission Implementing Regulation (EU) 2026/367 of 19 February 2026 amending Implementing Regulation (EU) 2019/2030 as regards administrative changes to the Union authorisation of the biocidal product family PAL IPA PRODUCT FAMILY
Date: 2026-02-19
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_202600367EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/367


20.2.2026







            COMMISSION IMPLEMENTING REGULATION (EU) 2026/367
of 19 February 2026
         
amending Implementing Regulation (EU) 2019/2030 as regards administrative changes to the Union authorisation of the biocidal product family ‘PAL 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 Article 50(2) thereof,

Whereas:







(1)


On 29 November 2019, Commission Implementing Regulation (EU) 2019/2030 (2) granted a Union authorisation, under number EU-0020463-0000, to Pal Hygiene Products Limited for the making available on the market and use of the biocidal product family ‘Pal IPA Product Family’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.












(2)


On 17 October 2024, Pal Hygiene Products Limited submitted notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), of administrative changes to the Union authorisation of the biocidal product family ‘PAL IPA PRODUCT FAMILY’, as referred to in Title 1 of the Annex to that Regulation. The notification was recorded in the Register for Biocidal Products (‘the Register’) under case number BC-KT100508-25. The notified proposed changes to that authorisation concern the addition of trade names and a change in the address of the manufacturing location of the biocidal product and the manufacturer.












(3)


On 11 November 2024, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinion (4) on the notified administrative changes to the Union authorisation of the biocidal product family ‘PAL IPA PRODUCT FAMILY’, together with a revised summary of product characteristics. In its opinion, the Agency concluded that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 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.












(4)


On 11 November 2024, the Agency transmitted to the Commission a revised summary of product characteristics of the Union authorisation of the biocidal product family ‘PAL IPA PRODUCT FAMILY’ in all official languages of the Union, covering all the administrative changes applied for, 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 ‘PAL IPA PRODUCT FAMILY’ to introduce the administrative changes requested by Pal Hygiene Products Limited.












(6)


Except for the amendments regarding the proposed administrative changes, all other information included in the summary of product characteristics of ‘PAL IPA PRODUCT FAMILY’, as set out in the Annex to Implementing Regulation (EU) 2019/2030, remains unchanged.












(7)


In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2019/2030 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of product characteristics in the Register in February 2024, the summary of product characteristics in that Annex should also include some minor editorial and layout changes.












(8)


Implementing Regulation (EU) 2019/2030 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
The Annex to Implementing Regulation (EU) 2019/2030 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, 19 February 2026.


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) 2019/2030 of 29 November 2019 granting a Union authorisation for the biocidal product family ‘PAL IPA PRODUCT FAMILY’ (OJ L 313, 4.12.2019, p. 51, ELI: http://data.europa.eu/eli/reg_impl/2019/2030/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)  ECHA Opinion No UAD-C-1775477-16-00/F of 11 November 2024 on the administrative change of the Union authorisation of the biocidal product family ‘PAL IPA PRODUCT FAMILY’, https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
Summary of product characteristics for a biocidal product family
Pal 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-0020463-0000

R4BP asset number: EU-0020463-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Pal 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


Pal Hygiene Products Limited




Address


Unit 5B & Unit 5H Fingal Bay Business Park K32 NY57 Balbriggan IE




Authorisation number


 


EU-0020463-0000





R4BP asset number



 


EU-0020463-0000




Date of the authorisation


 


24.12.2019




Expiry date of the authorisation


 


30.11.2029




1.4.   Manufacturer(s) of the product







Name of manufacturer


Pal International Limited




Address of manufacturer


Unit 3 Mountpark, Victoria Road, Ellistown LE67 1FA Coalville, Leicestershire United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Pal International Limited site 1 Unit 3 Mountpark, Victoria Road, Ellistown LE67 1FA Coalville, Leicestershire United Kingdom of Great Britain and Northern Ireland (the)




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 Baton Rouge Chemical Plant (BRCP), Exxon Mobil Chemical Plant, 4999 Scenic Highway 70897 Baton Rouge, Louisiana United States (the)













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)




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




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 - Pal IPA Product Family Wipes




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 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


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 /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


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Disinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of non-invasive medical devices, healthcare industries and other critical life science applications, and in industrial food and feed preparation areas.




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
1 minute contact time for mycobacteria
3 minute contact time for yeast




Category(ies) of users


professional




Pack sizes and packaging material


Impregnated 100 % polypropylene wipes in:






—


High density polyethylene (HDPE) canister with Polypropylene (PP) lid – 150 wipes (0.5 L), 200 wipes (2 L), 240 wipes (2 L)










—


PP bucket with PP lid – 500 wipes (8 L), 1 000  wipes (8 L), 1 500  wipes (8 L)




Impregnated 100 % polyester wipes in:






—


laminate film flow wrap packet sealed with PET/PE – 25, 50 or 100 wipes










—


Aluminium foil - 1 wipe








4.1.1.   Use-specific instructions for use

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

Do not use on surfaces sensitive to alcohol.
Acceptable use temperature (10-20°C)
For soiled surfaces, clean the surface carefully before application






1.


Follow agreed risk assessment policy guidelines regarding the use of Personal Protective Equipment (PPE).










2.


Choose the dispenser type and dispense the wipe.










3.


Wipe the surface in an S Shape moving from clean to dirty. Use the wipe flat not scrunched. Do not go over the same area twice with the same wipe.










4.


Use a fresh wipe if your wipe becomes soiled or dry.










5.


Make sure to wet surfaces completely










6.


Used wipes must be disposed in a closed container.










7.


Allow the surface to dry before use.




5.2.   Risk mitigation measures

Wash hands and exposed skin before meals and after use.
Avoid contact with eyes.
When performing disinfection in areas where members of the public may be present, persons should be prevented from entering the room until the room has been well ventilated.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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
5.4.   Instructions for safe disposal of the product and its packaging

Dispose of contents/container in accordance with local regulations.
Do not flush wipes down the toilet. Do not macerate.
Residual alcohol should be emptied prior to disposal of container.
Discard used wipes in the appropriate waste bin following local agreed guidelines.
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 container tightly closed.
Shelf-life: 2 years
6.   OTHER INFORMATION

Polypropylene or polyester wipes, 20-45 gsm, containing 1.7 – 7.5 ml product (0.93 – 4.12 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 1

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













Trade name(s)


Sirafan Alco Wipes


Market area: EU




Alcodes GF maxi wipes


Market area: EU




Medipal Alcohol Disinfectant Wipes


Market area: EU




Pal Tech Precision 70% IPA Wipes


Market area: EU




Pal TX IPA Surface Disinfectant Wipes


Market area: EU




Authorisation number


 


EU-0020463-0001 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)







ELI: http://data.europa.eu/eli/reg_impl/2026/367/oj
ISSN 1977-0677 (electronic edition)