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

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 [^ntr1-L_202600367EN.000101-E0001], and in particular Article 50(2) thereof,

Whereas:

• (1) On 29 November 2019, Commission Implementing Regulation (EU) 2019/2030 [^ntr2-L_202600367EN.000101-E0002] 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 [^ntr3-L_202600367EN.000101-E0003], 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 [^ntr4-L_202600367EN.000101-E0004] 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

[^ntr1-L_202600367EN.000101-E0001]: OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

[^ntr2-L_202600367EN.000101-E0002]: 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).

[^ntr3-L_202600367EN.000101-E0003]: 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).

[^ntr4-L_202600367EN.000101-E0004]: 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

1.2.   Product type(s)

1.3.   Authorisation holder

1.4.   Manufacturer(s) of the product

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

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

2.2.   Type(s) of formulation

PART II

SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

1.2.   Suffix to the authorisation number

1.3.   Product type(s)

2. META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

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

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Professional use

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).

• 1. Choose the dispenser type and dispense the wipe.

• 1. 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.

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

• 1. Make sure to wet surfaces completely

• 1. Used wipes must be disposed in a closed container.

• 1. 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

ELI: http://data.europa.eu/eli/reg_impl/2026/367/oj

ISSN 1977-0677 (electronic edition)