http://www.legislation.gov.uk/id/eur/2020/1995/contents/england

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...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...7.2.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...7.2.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...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...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...

Commission Implementing Regulation (EU) 2020/1995

of 4 December 2020

amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’

(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 50(2) thereof,

Whereas:

(1)

On 20 September 2018, a Union authorisation with authorisation number EU-0018397-0000 was granted by Commission Implementing Regulation (EU) 2018/12612 to HYPRED SAS for the making available on the market and use of the biocidal product family ‘Hypred’s iodine based products‘.

(2)

On 04 April 2019, HYPRED SAS submitted a notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/20133, in respect of administrative changes to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ as described in Title 1, Sections 1 and 2 of the Annex to that Regulation.

(3)

HYPRED SAS proposed the following changes to the summary of the product characteristics for the biocidal product family ‘Hypred’s iodine based products’, as set out in the Annex to Implementing Regulation (EU) 2018/1261: (a) the addition of names for the biocidal product family in Section 7.1 of the third information level: individual products in the meta SPCs 1, 2, 3 and 5; (b) the change of the name of the authorisation holder in Section 1.3; (c) the addition of two manufacturers for the active substance and their respective manufacturing sites in Section 1.5; (d) the change of administrative details of the manufacturer in Section 1.4; (e) changes of administrative details of the location of existing manufacturing sites, and addition of location of new manufacturing sites in Section 1.4. The notification was recorded under case number BC-KC049719-36 in the Register for Biocidal Products.

(4)

On 19 June 2019, the Agency submitted to the Commission an opinion on the proposed changes, 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 falls under the category of change set out in Article 50(3)(a) of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 to that Regulation are still met.

(5)

On 28 June 2019, 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.

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to amend the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION: