http://www.legislation.gov.uk/id/eur/2020/1991/contents

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...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 4.1.1.Use-specific instructions for use 4.1.2.Use-specific risk mitigation measures 4.1.3.Where specific to the use, the particulars of likely direct...4.1.4.Where specific to the use, the instructions for safe disposal...4.1.5.Where specific to the use, the conditions of storage and...4.2.Use description 4.2.1.Use-specific instructions for use 4.2.2.Use-specific risk mitigation measures 4.2.3.Where specific to the use, the particulars of likely direct...4.2.4.Where specific to the use, the instructions for safe disposal...4.2.5.Where specific to the use, the conditions of storage and...4.3.Use description 4.3.1.Use-specific instructions for use 4.3.2.Use-specific risk mitigation measures 4.3.3.Where specific to the use, the particulars of likely direct...4.3.4.Where specific to the use, the instructions for safe disposal...4.3.5.Where specific to the use, the conditions of storage and...4.4.Use description 4.4.1.Use-specific instructions for use 4.4.2.Use-specific risk mitigation measures 4.4.3.Where specific to the use, the particulars of likely direct...4.4.4.Where specific to the use, the instructions for safe disposal...4.4.5.Where specific to the use, the conditions of storage and...5.GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1.Instructions for use 5.2.Risk mitigation measures 5.3.Particulars of likely direct or indirect effects, first aid instructions...5.4.Instructions for safe disposal of the product and its packaging...5.5.Conditions of storage and shelf-life of the product under normal...6.OTHER INFORMATION 7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1...7.1.Trade name(s), authorisation number and specific composition of each individual...META SPC 2 1.META SPC 2 ADMINISTRATIVE INFORMATION 1.1.Meta SPC 2 identifier 1.2.Suffix to the authorisation number 1.3.Product type(s) 2.META SPC 2 COMPOSITION 2.1.Qualitative and quantitative information on the composition of the meta...2.2.Type(s) of formulation of the meta SPC 2 3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 4.AUTHORISED USE(S) OF THE META SPC 2 4.1.Use description 4.1.1.Use-specific instructions for use 4.1.2.Use-specific risk mitigation measures 4.1.3.Where specific to the use, the particulars of likely direct...4.1.4.Where specific to the use, the instructions for safe disposal...4.1.5.Where specific to the use, the conditions of storage and...4.2.Use description 4.2.1.Use-specific instructions for use 4.2.2.Use-specific risk mitigation measures 4.2.3.Where specific to the use, the particulars of likely direct...4.2.4.Where specific to the use, the instructions for safe disposal...4.2.5.Where specific to the use, the conditions of storage and...5.GENERAL DIRECTIONS FOR USE OF THE META SPC 2 5.1.Instructions for use 5.2.Risk mitigation measures 5.3.Particulars of likely direct or indirect effects, first aid instructions...5.4.Instructions for safe disposal of the product and its packaging...5.5.Conditions of storage and shelf-life of the product under normal...6.OTHER INFORMATION 7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2...7.1.Trade name(s), authorisation number and specific composition of each individual...META SPC 3 1.META SPC 3 ADMINISTRATIVE INFORMATION 1.1.Meta SPC 3 identifier 1.2.Suffix to the authorisation number 1.3.Product type(s) 2.META SPC 3 COMPOSITION 2.1.Qualitative and quantitative information on the composition of the meta...2.2.Type(s) of formulation of the meta SPC 3 3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 4.AUTHORISED USE(S) OF THE META SPC 3 4.1.Use description 4.1.1.Use-specific instructions for use 4.1.2.Use-specific risk mitigation measures 4.1.3.Where specific to the use, the particulars of likely direct...4.1.4.Where specific to the use, the instructions for safe disposal...4.1.5.Where specific to the use, the conditions of storage and...4.2.Use description 4.2.1.Use-specific instructions for use 4.2.2.Use-specific risk mitigation measures 4.2.3.Where specific to the use, the particulars of likely direct...4.2.4.Where specific to the use, the instructions for safe disposal...4.2.5.Where specific to the use, the conditions of storage and...4.3.Use description 4.3.1.Use-specific instructions for use 4.3.2.Use-specific risk mitigation measures 4.3.3.Where specific to the use, the particulars of likely direct...4.3.4.Where specific to the use, the instructions for safe disposal...4.3.5.Where specific to the use, the conditions of storage and...4.4.Use description 4.4.1.Use-specific instructions for use 4.4.2.Use-specific risk mitigation measures 4.4.3.Where specific to the use, the particulars of likely direct...4.4.4.Where specific to the use, the instructions for safe disposal...4.4.5.Where specific to the use, the conditions of storage and...5.GENERAL DIRECTIONS FOR USE OF THE META SPC 3 5.1.Instructions for use 5.2.Risk mitigation measures 5.3.Particulars of likely direct or indirect effects, first aid instructions...5.4.Instructions for safe disposal of the product and its packaging...5.5.Conditions of storage and shelf-life of the product under normal...6.OTHER INFORMATION 7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3...7.1.Trade name(s), authorisation number and specific composition of each individual...META SPC 4 1.META SPC 4 ADMINISTRATIVE INFORMATION 1.1.Meta SPC 4 identifier 1.2.Suffix to the authorisation number 1.3.Product type(s) 2.META SPC 4 COMPOSITION 2.1.Qualitative and quantitative information on the composition of the meta...2.2.Type(s) of formulation of the meta SPC 4 3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 4.AUTHORISED USE(S) OF THE META SPC 4 4.1.Use description 4.1.1.Use-specific instructions for use 4.1.2.Use-specific risk mitigation measures 4.1.3.Where specific to the use, the particulars of likely direct...4.1.4.Where specific to the use, the instructions for safe disposal...4.1.5.Where specific to the use, the conditions of storage and...4.2.Use description 4.2.1.Use-specific instructions for use 4.2.2.Use-specific risk mitigation measures 4.2.3.Where specific to the use, the particulars of likely direct...4.2.4.Where specific to the use, the instructions for safe disposal...4.2.5.Where specific to the use, the conditions of storage and...5.GENERAL DIRECTIONS FOR USE OF THE META SPC 4 5.1.Instructions for use 5.2.Risk mitigation measures 5.3.Particulars of likely direct or indirect effects, first aid instructions...5.4.Instructions for safe disposal of the product and its packaging...5.5.Conditions of storage and shelf-life of the product under normal...6.OTHER INFORMATION 7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4...7.1.Trade name(s), authorisation number and specific composition of each individual...META SPC 5 1.META SPC 5 ADMINISTRATIVE INFORMATION 1.1.Meta SPC 5 identifier 1.2.Suffix to the authorisation number 1.3.Product type(s) 2.META SPC 5 COMPOSITION 2.1.Qualitative and quantitative information on the composition of the meta...2.2.Type(s) of formulation of the meta SPC 5 3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 4.AUTHORISED USE(S) OF THE META SPC 5 4.1.Use description 4.1.1.Use-specific instructions for use 4.1.2.Use-specific risk mitigation measures 4.1.3.Where specific to the use, the particulars of likely direct...4.1.4.Where specific to the use, the instructions for safe disposal...4.1.5.Where specific to the use, the conditions of storage and...4.2.Use description 4.2.1.Use-specific instructions for use 4.2.2.Use-specific risk mitigation measures 4.2.3.Where specific to the use, the particulars of likely direct...4.2.4.Where specific to the use, the instructions for safe disposal...4.2.5.Where specific to the use, the conditions of storage and...5.GENERAL DIRECTIONS FOR USE OF THE META SPC 5 5.1.Instructions for use 5.2.Risk mitigation measures 5.3.Particulars of likely direct or indirect effects, first aid instructions...5.4.Instructions for safe disposal of the product and its packaging...5.5.Conditions of storage and shelf-life of the product under normal...6.OTHER INFORMATION 7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5...7.1.Trade name(s), authorisation number and specific composition of each individual...META SPC 6 1.META SPC 6 ADMINISTRATIVE INFORMATION 1.1.Meta SPC 6 identifier 1.2.Suffix to the authorisation number 1.3.Product type(s) 2.META SPC 6 COMPOSITION 2.1.Qualitative and quantitative information on the composition of the meta...2.2.Type(s) of formulation of the meta SPC 6 3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 4.AUTHORISED USE(S) OF THE META SPC 6 4.1.Use description 4.1.1.Use-specific instructions for use 4.1.2.Use-specific risk mitigation measures 4.1.3.Where specific to the use, the particulars of likely direct...4.1.4.Where specific to the use, the instructions for safe disposal...4.1.5.Where specific to the use, the conditions of storage and...4.2.Use description 4.2.1.Use-specific instructions for use 4.2.2.Use-specific risk mitigation measures 4.2.3.Where specific to the use, the particulars of likely direct...4.2.4.Where specific to the use, the instructions for safe disposal...4.2.5.Where specific to the use, the conditions of storage and...5.GENERAL DIRECTIONS FOR USE OF THE META SPC 6 5.1.Instructions for use 5.2.Risk mitigation measures 5.3.Particulars of likely direct or indirect effects, first aid instructions...5.4.Instructions for safe disposal of the product and its packaging...5.5.Conditions of storage and shelf-life of the product under normal...6.OTHER INFORMATION 7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6...7.1.Trade name(s), authorisation number and specific composition of each individual...META SPC 7 1.META SPC 7 ADMINISTRATIVE INFORMATION 1.1.Meta SPC 7 identifier 1.2.Suffix to the authorisation number 1.3.Product type(s) 2.META SPC 7 COMPOSITION 2.1.Qualitative and quantitative information on the composition of the meta...2.2.Type(s) of formulation of the meta SPC 7 3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 4.AUTHORISED USE(S) OF THE META SPC 7 4.1.Use description 4.1.1.Use-specific instructions for use 4.1.2.Use-specific risk mitigation measures 4.1.3.Where specific to the use, the particulars of likely direct...4.1.4.Where specific to the use, the instructions for safe disposal...4.1.5.Where specific to the use, the conditions of storage and...4.2.Use description 4.2.1.Use-specific instructions for use 4.2.2.Use-specific risk mitigation measures 4.2.3.Where specific to the use, the particulars of likely direct...4.2.4.Where specific to the use, the instructions for safe disposal...4.2.5.Where specific to the use, the conditions of storage and...4.3.Use description 4.3.1.Use-specific instructions for use 4.3.2.Use-specific risk mitigation measures 4.3.3.Where specific to the use, the particulars of likely direct...4.3.4.Where specific to the use, the instructions for safe disposal...4.3.5.Where specific to the use, the conditions of storage and...4.4.Use description 4.4.1.Use-specific instructions for use 4.4.2.Use-specific risk mitigation measures 4.4.3.Where specific to the use, the particulars of likely direct...4.4.4.Where specific to the use, the instructions for safe disposal...4.4.5.Where specific to the use, the conditions of storage and...5.GENERAL DIRECTIONS FOR USE OF THE META SPC 7 5.1.Instructions for use 5.2.Risk mitigation measures 5.3.Particulars of likely direct or indirect effects, first aid instructions...5.4.Instructions for safe disposal of the product and its packaging...5.5.Conditions of storage and shelf-life of the product under normal...6.OTHER INFORMATION 7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7...7.1.Trade name(s), authorisation number and specific composition of each individual...7.2.Trade name(s), authorisation number and specific composition of each individual...META SPC 8 1.META SPC 8 ADMINISTRATIVE INFORMATION 1.1.Meta SPC 8 identifier 1.2.Suffix to the authorisation number 1.3.Product type(s) 2.META SPC 8 COMPOSITION 2.1.Qualitative and quantitative information on the composition of the meta...2.2.Type(s) of formulation of the meta SPC 8 3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8 4.AUTHORISED USE(S) OF THE META SPC 8 4.1.Use description 4.1.1.Use-specific instructions for use 4.1.2.Use-specific risk mitigation measures 4.1.3.Where specific to the use, the particulars of likely direct...4.1.4.Where specific to the use, the instructions for safe disposal...4.1.5.Where specific to the use, the conditions of storage and...4.2.Use description 4.2.1.Use-specific instructions for use 4.2.2.Use-specific risk mitigation measures 4.2.3.Where specific to the use, the particulars of likely direct...4.2.4.Where specific to the use, the instructions for safe disposal...4.2.5.Where specific to the use, the conditions of storage and...5.GENERAL DIRECTIONS FOR USE OF THE META SPC 8 5.1.Instructions for use 5.2.Risk mitigation measures 5.3.Particulars of likely direct or indirect effects, first aid instructions...5.4.Instructions for safe disposal of the product and its packaging...5.5.Conditions of storage and shelf-life of the product under normal...6.OTHER INFORMATION 7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8...7.1.Trade name(s), authorisation number and specific composition of each individual...7.2.Trade name(s), authorisation number and specific composition of each individual...

Commission Implementing Regulation (EU) 2020/1991

of 27 November 2020

granting a Union authorisation for the biocidal product family ‘perform-IPA’

(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 products1, and in particular Article 44(5) thereof,

Whereas:

(1)

On 19 April 2016, Schuelke & Mayr GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘perform-IPA’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-AB023095-72 in the Register for Biocidal Products.

(2)

‘perform-IPA’ 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 27 August 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4)

On 7 April 2020, the Agency submitted to the Commission an opinion2, the draft summary of the biocidal product characteristics (‘SPC’) of ‘perform-IPA’ 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 ‘perform-IPA’ 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 draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(6)

On 27 April 2020, 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 ‘perform-IPA’.

(8)

According to the opinion of the Agency, as regards the non-active substance diethyl phthalate contained in ‘perform-IPA’, it was not possible to conclude whether it meets the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/21003 within the period for the evaluation of the application. Further examination of diethyl phthalate should therefore take place. If it is concluded that diethyl phthalate is considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘perform-IPA’ in accordance with Article 48 of Regulation (EU) No 528/2012.

(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: