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)
EU Decision 2018/1622 · Adopted 29 October 2018 · Extends to United Kingdom
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 productsf1, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1)
(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For a number of active substance/product-type combinations included in that list, all the participants have withdrawn their support in a timely manner.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:
Annotations to the whole text
Footnotes
- f1
- f2
-
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).
- f3
-
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).
Contents
1
The active substances listed in the Annex are not approved for the product-types indicated therein.
2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
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 X1939 Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ SK Mixture Not available 2, 3, 4, 5 824 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