COMMISSION IMPLEMENTING DECISION (EU) 2018/1622

of 29 October 2018

on the non-approval of certain active substances in biocidal products pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council

(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 third subparagraph of Article 89(1) thereof,

Whereas:

(1) Commission Delegated Regulation (EU) No 1062/2014 (2), as amended by Delegated Regulation (EU) 2017/698 (3), establishes in its Annex II a list of active substance/product-type combinations included in the review programme of existing active substances in biocidal products on 3 February 2017.

(2) For a number of active substance/product-type combinations included in that list, all the participants have withdrawn their support in a timely manner.

(3) As regards some active substances generated in situ, the name of those active substances and their precursors which are supported in the review programme has been clarified in a more precise manner. This has lead in certain cases to a redefinition of the active substance in accordance with Article 13 of Delegated Regulation (EU) No 1062/2014.

(4) A notification was published inviting persons wishing to support those active substance/product-types combinations which have been redefined and currently not supported, including the generation in situ of the active substances for the product-types listed in Annex II to Delegated Regulation (EU) No 1062/2014, so that the role of participant may be taken over.

(5) For some active substance/product-type combinations no notification has been submitted or a notification has been submitted and rejected pursuant to paragraphs 4 or 5 of Article 17 of Delegated Regulation (EU) No 1062/2014.

(6) In accordance with Article 20 of Delegated Regulation (EU) No 1062/2014, those active substance/product-type combinations should not be approved for use in biocidal products.

(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DECISION:

Article 1

The active substances listed in the Annex are not approved for the product-types indicated therein.

Article 2

This Decision shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union

Done at Brussels, 29 October 2018.

For the Commission

The President

Jean-Claude JUNCKER

(1)

OJ L 167, 27.6.2012, p. 1

(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (

OJ L 294, 10.10.2014, p. 1

(3) Commission Delegated Regulation (EU) 2017/698 of 3 February 2017 amending Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (

OJ L 103, 19.4.2017, p. 1

ANNEX

Active substance/product type combinations not approved, including any nanomaterial forms:

— the generation in situ of the active substances for the product-types listed in Annex II to Delegated Regulation (EU) No 1062/2014, except when the active substance is generated from the precursor(s) mentioned in the entry of the table of that Annex for the concerned active substance/product-type combinations;

— the substance/product-type combinations listed in the table below, including any generation in situ of these substances using any precursor that is not mentioned in Annex II to Delegated Regulation (EU) No 1062/2014:

Entry Number in Annex II to Delegated Regulation (EU) No 1062/2014	Substance name	Rapporteur Member State	EC number	CAS number	Product-type(s)
60	Citric acid	BE	201-069-1	77-92-9	1
172	Cetylpyridinium Chloride	UK	204-593-9	123-03-5	2
195	Sodium 2-biphenylate	ES	205-055-6	132-27-4	1, 2, 3
288	N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide (Dichlofluanid)	UK	214-118-7	1085-98-9	7
365	Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione)	SE	223-296-5	3811-73-2	3
401	Silver	SE	231-131-3	7440-22-4	9
405	Sulphur dioxide	DE	231-195-2	7446-09-5	4
424	Sodium bromide	NL	231-599-9	7647-15-6	2, 11, 12
458	Ammonium sulphate	UK	231-984-1	7783-20-2	11,12
1016	Silver chloride	SE	232-033-3	7783-90-6	10, 11
515	Ammonium bromide	SE	235-183-8	12124-97-9	11, 12
526	Potassium 2-biphenylate	ES	237-243-9	13707-65-8	6, 9, 10, 13
529	Bromine chloride	NL	237-601-4	13863-41-7	11
541	Sodium p-chloro-m-cresolate	FR	239-825-8	15733-22-9	1, 2, 3, 6, 9, 13
609	Mixture of cis- and trans-p-menthane-3,8 diol (Citriodiol)	UK	Not available	Not available	19
620	Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS)	MT	259-709-0	55566-30-8	2
673	Didecyldimethylammonium chloride (DDAC (C8-10))	IT	270-331-5	68424-95-3	5
785	6-(Phthalimido)peroxyhexanoic acid (PAP)	IT	410-850-8	128275-31-0	3, 4
792	Tetrachlorodecaoxide complex (TCDO)	DE	420-970-2	92047-76-2	1
952	Bacillus sphaericus other than Bacillus sphaericus 2362, strain ABTS-1743	IT	Micro-organism	143447-72-7	18
955	Bacillus thuringiensis subsp.israelensis Serotype H14, other than strain AM65-52 and other than strain SA3A	IT	Micro-organism	Not available	18
957	Bacillus subtilis	DE	Micro-organism	Not available	3
939	Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ	SK	Mixture	Not available	2, 3, 4, 5, 11, 12
824	Silver zinc zeolite	SE	Not available	130328-20-0	5
1013	Silver copper zeolite	SE	Not available	130328-19-7	5
835	Esfenvalerate/(S)-.alpha.-Cyano-3-phenoxybenzyl (S)-2-(4-chlorophenyl)-3-methylbutyrate (Esfenvalerate)	PT	Plant protection product	66230-04-4	18