COMMISSION IMPLEMENTING REGULATION (EU) 2019/2030

of 29 November 2019

granting a Union authorisation for 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 the first subparagraph of Article 44(5) thereof,

Whereas:

(1) On 29 June 2016, Pal Hygiene Products Limited, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Pal IPA Product Family’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of United Kingdom had agreed to evaluate the application. The application was recorded under the case number BC-DY025578-07 in the Register for Biocidal Products.

(2) ‘Pal IPA Product Family’ contains propan-2-ol, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

(3) On 22 August 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4) On 25 March 2019, the Agency submitted to the Commission an opinion (2), including the proposed terms and conditions of the authorisation, the draft summary of the biocidal product characteristics (‘SPC’) of ‘Pal IPA Product Family’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘Pal IPA Product Family’ is a ‘biocidal product family’ within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the proposed terms and conditions and the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(6) On 4 June 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Pal IPA Product Family’.

(8) In the opinion the Agency also recommends that a long-term storage test at ambient temperature for wipes in their commercial packaging be conducted by the authorisation holder as a condition in the authorisation. The Commission agrees with that recommendation and considers that the submission of this test should be a condition relating to the making available on the market and use of the biocidal product family pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1)(d) of that Regulation on the basis of the existing data.

(9) 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

A Union authorisation with authorisation number EU-0020463-0000 is granted to Pal Hygiene Products Limited for the making available on the market and use of the biocidal product family ‘Pal IPA Product Family’, subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in the Annex II.

The Union authorisation is valid from 24 December 2019 until 30 November 2029.

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, 29 November 2019.

For the Commission

The President

Jean-Claude JUNCKER

(1)  

OJ L 167, 27.6.2012, p. 1

.

(2)  ECHA opinion of 28 February 2019 on the Union authorisation of ‘Pal IPA Product Family’ (ECHA/BPC/223/2019).

ANNEX I

TERMS AND CONDITIONS

(EU-0020463-0000)

The authorisation holder shall conduct a long-term storage test at ambient temperature for wipes in their commercial packaging.

By 31 July 2021 the authorisation holder shall submit the results of the test to the Agency.

ANNEX II

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

Pal 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-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 biocidal products

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)

Meta SPC 1

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 1

4.1.   

Use description

Table 1. Use # 1 — Professional use

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

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.

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/m

3

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

(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.