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.)
Date: 2018-10-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: chemical product, market approval, marketing standard, plant health control, plant health product








L_2018271EN.01002601.xml










30.10.2018   


EN


Official Journal of the European Union


L 271/26








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For a number of active substance/product-type combinations included in that list, all the participants have withdrawn their support in a timely manner.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